Umedo

Certificate verification page

Certification scheme

MDD 93/42/EEC Annex V

Certificate number

EC10 0091 2020 0309 rev.1

Certificate history

EC10 0091 2020 0309 rev.1 (First revision | 21.May.2021)
       – new packaging types

EC10 0091 2020 0309 (Initial issue | 14.January.2021)

Manufacturer/Holder of certificate

UMEDO GROUP LLC

62B, Vatutin general Street, Makariv town, Makariv district, Kyiv region, 08000, Ukraine

Other sites
–
Effective from

21.May.2021

Suspension period

From 05 March 2023

 

Withdrawn on
–
Validity status
Suspended

(Not possible to perform surveillance audit due to ongoing war conflict)

Products within scope

Sterile hypodermic single use syringe with needle

Sterile single use syringe

Hypodermic sterile single use needle

 

Specifications

Syringe sizes:

1 ml, 2 ml, 3 ml, 5 ml, 10 ml, 20 ml

Needle sizes:

18G x 1 1/2″
21G x 1 1/2″
21G x 1 3/4″
22G x 1 1/4″
22G x 1 1/2″
22G x 1 3/4″
23G x 1 1/4″
23G x 1″
25G x 5/8″
25G x 1″
26G x 1/2″
27G x 1/2”
Types

Sterile hypodermic single-use syringe, Luer Slip, “Umedo Group”, 1 ml (3-part, with needle 27G x ½” (0,4x13mm))
Sterile hypodermic single-use syringe, Luer Slip, “Umedo Group”, 1 ml (3-part, with needle 26G x ½” (0,45x13mm))
Sterile hypodermic single-use syringe, Luer Slip, “Umedo Group”, 1 ml (3-part, with needle 23G x 1” (0,6×25 mm))
Sterile hypodermic single-use syringe, Luer Slip, “Umedo Group”, 1 ml (3-part, with needle 25G x 1” (0,5×25 mm))
Sterile hypodermic single-use syringe, Luer Lock, “Umedo Group”, 1 ml (3-part, with needle 27G x ½” (0,4x13mm))
Sterile hypodermic single-use syringe, Luer Lock, ” Umedo Group”, 1 ml (3-part, with needle 26G x ½” (0,45x13mm))
Sterile hypodermic single-use syringe, Luer Lock, “Umedo Group”, 1 ml (3-part, with needle 23G x 1” (0,6x25mm))
Sterile hypodermic single-use syringe, Luer Lock, “Umedo Group”, 1 ml (3-part, with needle 25G x 1” (0,5x25mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 25G x 5/8 ” (0,5 x 16 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 25G x 1” (0,5 x 25 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 23G x 1” (0,6 x 25 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 21G x 1 ½” (0,8 x 38mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 25G x 5/8” (0,5 x 16mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 25G x 1” (0,5 x 25mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 23G x 1 ” (0,6 x 25mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 22G x 1 ¾”(0,7 x 44mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 21G x1 ½” (0,8 x 38mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needle 21G x 1 ¾”(0,8 x 44mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 25G x 5/8” (0,5 x 16mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 25G x 1” (0,5 x 25mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 23G x 1” (0,6 x 25mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 21G x1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 25G x 5/8 ” (0,5 x 16 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 25G x 1” (0,5 x 25 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 23G x 1 ”  (0,6 x 25 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 23G x 1 ¼ ” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 21G x 1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 25G x 5/8” (0,5 x 16 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 25G x 1” (0,5 x 25 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 23G x 1” (0,6 x 25 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 21G x 1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 25G x 5/8” (0,5 x 16 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 25G x 1” (0,5 x 25mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 23G x 1 (0,6mm x 25 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 21G x 1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts, with needle 22G x 1 ¼”  (0,7 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts, with needle 22G x 1 ¾ ” (0,7 x 44  mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts, with needle 21G x 1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts, with needle 18Gx1 1/2 (1,2 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 23G x 1 ¼ ” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 21G x1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 18G x 1 ½ ” (1,2 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts, with needle 22G x 1 ½ ” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts, with needle 21G x 1 ½ ” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts, with needle 18G x 1 ½” (1,2 x 38mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group, 20 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock “Umedo Group, 20 ml (3-parts, with needle 22G x 1 ¼” (0,7 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group, 20 ml (3-parts, with needle 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group, 20 ml (3-parts, with needle 22G x 1 ¾” (0,7 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group, 20 ml (3-parts, with needle 21G x 1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group, 20 ml (3-parts, with needle 21G x 1 ¾” (0,8 x 44 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group, 20 ml (3-parts, with needle 18G x 1 ½ ” (1,2 x 38 mm))
Sterile hypodermic single use, Luer Slip, “Umedo Group”, 1ml (3-parts, with two needles 27G x ½” (0,4 x 13 mm), 25G x 5/8” (0,5 x 16 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 1 ml (3-parts, with needle 27G x ½” (0,4 x 13 mm), 25G x 5/8” (0,5 x 16 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 2ml (3-parts, with two needles 25G x 1 ” (0,5 x 25 mm), 23G x 1 ¼ ” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts, with needles 25G x 1” (0,5 x 25 mm), 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 3ml (3-parts, with two needles 25G x 1 ” (0,5 x 25 mm), 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts, with needles 25G x 1” (0,5 x 25 mm), 23G x 1 ¼” (0,6 x 32 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 5ml (3-parts, with two needles 23G x 1 ¼” (0,6 x 32 mm), 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts, with needles 23G x 1 ¼” (0,6 x 32 mm), 22G x 1 ½” (0,7 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 10ml (3-parts, with two needles 23G x 1 ¼” (0,6 x 32mm), 21G x1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32 mm), 21G x 1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 20ml (3-parts, with two needles 23G x 1 ¼” (0,6 x 32 mm), 21G x 1 ½” (0,8 x 38 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 20 ml (3-parts, with needle 23G x 1 ¼” (0,6 x 32mm), 21G x 1 ½ ” (0,8 x 38 mm))

Hypodermic needle for single use sterile 0,4 mm x13 mm (27Gx½”)
Hypodermic needle for single use sterile 0,45 mm x13 mm (26Gx½”)
Hypodermic needle for single use sterile 0,5 mm x 16 mm (25Gx5/8”)
Hypodermic needle for single use sterile 0,5 mm x 25 mm (25Gx1”)
Hypodermic needle for single use sterile 0,6 mm x 25 mm (23Gx1”)
Hypodermic needle for single use sterile 0,6 mm x32 mm (23Gx1¼”)
Hypodermic needle for single use sterile 0,7 mm x 32 mm (22Gx1¼”)
Hypodermic needle for single use sterile 0,7 mm x 38 mm (22Gx1½”)
Hypodermic needle for single use sterile 0,7 mm x 44 mm (22Gx1¾”)
Hypodermic needle for single use sterile 0,8 mm x 38 mm (21Gx1½”)
Hypodermic needle for single use sterile 0,8 mm x 44 mm (21Gx1¾”)
Hypodermic needle for single use sterile 1,2 mm x 38 mm (18Gx1½”)

Sterile single use syringe, Luer Slip, “Umedo Group”, 1 ml (3-parts)
Sterile single use syringe, Luer Lock, “Umedo Group”, 1 ml (3-parts)
Sterile single use syringe, Luer Slip, “Umedo Group”, 2 ml (3-parts)
Sterile single use syringe, Luer Lock, “Umedo Group”, 2 ml (3-parts)
Sterile single use syringe, Luer Slip, “Umedo Group”, 3 ml (3-parts)
Sterile single use syringe, Luer Lock, “Umedo Group”, 3 ml (3-parts)
Sterile single use syringe, Luer Slip, “Umedo Group”, 5 ml (3-parts)
Sterile single use syringe, Luer Lock, “Umedo Group”, 5 ml (3-parts)
Sterile single use syringe, Luer Slip, “Umedo Group”, 10 ml (3-parts)
Sterile single use syringe, Luer Lock, “Umedo Group”, 10 ml (3-parts)
Sterile single use syringe, Luer Slip, “Umedo Group”, 20 ml (3-parts)
Sterile single use syringe, Luer Lock, “Umedo Group, 20 ml (3-parts)