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Bbd

by Jiangsu Kanghua Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref SY-3P-5-01, IV-01, Ne-21G-38, 19GX1 1/2", Ne-25G-16, SY-3P-10-02, SY-3P-20-01, SY-3P-20-04, SY-3P-20-03, IV-10, IV-11, SY-3P-20-02, Ne-23G-38, TF-02, Ne-26G-16Model 5ML 3-part，Luer Slip，mounted with needle 21GX1 1/2" ，Latex Gasket，Transparent Barrel，White Plunger, DEHP-free, ￠8 Air Vent, Large Size Drip Chamber with Microcore, ￠14.2 Solution Filter, Accurate Flow Regulator, Large Size ABS Flow Regulator, Y Injection Site, Luer Lock Connector with Cap, 2 meters of tube, PE, 21GX1 1/2", 25GX5/8", 10ml 3-Part Luer Lock, With Mounted Needle 21GX1 1/2”, Latex Gasket, Transparent Barrel, White Plunger, 20ml 3-part luer slip syringe with mounted needle UNIT PACKING: Blister INNER PACKING:Box, 20ml 3-part luer lock syringe with mounted needle UNIT PACKING: Blister INNER PACKING:Box, 20ml 3-Part Luer Lock, With Side Needle 21GX1 1/2", Transparent Barrel, Latex Gasket, White Plunger, Plastic spike with φ6 blue air-vent, PE protector, small drip chamber with φ13.5 filter, middle size PP flow regulator( white cover blue wheel), Y site, luer lock connector with cap, 2m DEHP free tube,PE, Plastic spike with φ6 blue air-vent, PE protector, extra small drip chamber with φ12.3 filter, middle size PP flow regulator( white cover blue wheel), latex free injection site, luer lock connector with cap, 2m DEHP free tube, PE, 20ml 3-part luer slip syringe with side needle UNIT PACKING: Blister INNER PACKING:Box, 23GX1 1/2", Plastic spike without air-vent, PE protector, drip chamber, net shape filter, medium size ABS flow regulator( white cover red wheel), latex free injection site, luer lock connector with cap, 1.8m PVC DEHP FREE tubing, 26GX5/8"

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06935491700242 Basic UDI-DIDate10 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Disposable Syringes
Disposable Infusion Sets
Sterile Hypodermic Needles for Single Use
Sterile Hypodermic Needle for Single Use
Disposable Syringe
Disposable Syringes with Needle
Disposable Infusion Set without Needle
Disposable Transfusion Sets without Needle
Model / Reference
5ML 3-part，Luer Slip，mounted with needle 21GX1 1/2" ，Latex Gasket，Transparent Barrel，White Plunger, SY-3P-5-01, DEHP-free, ￠8 Air Vent, Large Size Drip Chamber with Microcore, ￠14.2 Solution Filter, Accurate Flow Regulator, Large Size ABS Flow Regulator, Y Injection Site, Luer Lock Connector with Cap, 2 meters of tube, PE, IV-01, 21GX1 1/2", Ne-21G-38, 19GX1 1/2", 25GX5/8", Ne-25G-16, 10ml 3-Part Luer Lock, With Mounted Needle 21GX1 1/2”, Latex Gasket, Transparent Barrel, White Plunger, SY-3P-10-02, 20ml 3-part luer slip syringe with mounted needle UNIT PACKING: Blister INNER PACKING:Box, SY-3P-20-01, 20ml 3-part luer lock syringe with mounted needle UNIT PACKING: Blister INNER PACKING:Box, SY-3P-20-04, 20ml 3-Part Luer Lock, With Side Needle 21GX1 1/2", SY-3P-20-03, Plastic spike with φ6 blue air-vent, PE protector, small drip chamber with φ13.5 filter, middle size PP flow regulator( white cover blue wheel), Y site, 2m DEHP free tube, IV-10, extra small drip chamber with φ12.3 filter, latex free injection site, IV-11, 20ml 3-part luer slip syringe with side needle UNIT PACKING: Blister INNER PACKING:Box, SY-3P-20-02, 23GX1 1/2", Ne-23G-38, Plastic spike without air-vent, drip chamber, net shape filter, medium size ABS flow regulator( white cover red wheel), 1.8m PVC DEHP FREE tubing, TF-02, 26GX5/8", Ne-26G-16
Primary DI / UDI-DI
06935491700242, 06935491700228, 06935491700211, 06935491700327, 06935491700266, 06935491700297, 06935491701355, 06935491701362, 06935491700303, 06935491701188, 06935491701195, 06935491700358, 06935491701331, 06935491701348, 06935491700341
Basic UDI-DI
B-06935491700242, B-06935491700228, B-06935491700211, B-06935491700327, B-06935491700266, B-06935491700297, B-06935491701355, B-06935491701362, B-06935491700303, B-06935491701188, B-06935491701195, B-06935491700358, B-06935491701331, B-06935491701348, B-06935491700341
EMDN Code
A020102010201, A03010103, A0101010102, A020102020101, A03010101, A03010102
Device Class
Class IIa
Class I
Market of Registration
Greece
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033842
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Kanghua Medical Equipment Co., Ltd.

See all devices from Jiangsu Kanghua Medical Equipment Co., Ltd. →

Properties

  • Sterile
  • Contains Latex YesEUDAMEDNoEUDAMED
  • Administering Medicine YesEUDAMEDNoEUDAMED
  • Measuring Function YesEUDAMEDNoEUDAMED

Other properties (7)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No