Umedo - bqs. certification body

Certificate verification page

Certification scheme

MDD 93/42/EEC Annex V

Certificate number

EC10 0091 2020 0309

Certificate history

QEC10 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

14.January.2021

Suspension period

–

Withdrawn on

–

Validity status

Valid

Scope

Manufacturing and selling of medical devices: sterile hypodermic single-use syringes with needle

Products within scope

Sterile hypodermic single use syringe with 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-parts, with needle 27G x ½” (0,4 x 13 mm))
Sterile hypodermic single use syringe, Luer Slip, “Umedo Group”, 1 ml (3-parts, with needle 26G x ½” (0,45 x 13 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group”, 1 ml (3-parts, with needle 27G x ½” (0,4 x 13 mm))
Sterile hypodermic single use syringe, Luer Lock, “Umedo Group “, 1 ml (3-parts, with needle 26G x ½” (0,45 x 13 mm))
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))