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Sterile Hypodermic Needles for Single Use

by Changzhou Shuangma Medical Devices Co., Ltd 6 variants

Ref 1208Model 0.4×15RWLB,0.45×15RWLB,0.5×20RWLB,0.5×36RWLB,0.55×20RWLB,0.6×25TWLB,0.7×30TWLB,0.8×36TWLB,0.9×36TWLB,1.1×30TWLB,1.2×30TWLB,30G×1/2（0.3×12.7mm）,21G×1 1/2,23G×1,19G×1 1/2（1.1×32mm）,22G×1 1/4（0.7×32mm）,18GX1 1/2

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69451447004ZSZ8M Basic UDI-DIDate28 May 2024RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
0.4×15RWLB, 0.45×15RWLB, 0.5×20RWLB, 0.5×36RWLB, 0.55×20RWLB, 0.6×25TWLB, 0.7×30TWLB, 0.8×36TWLB, 0.9×36TWLB, 1.1×30TWLB, 1.2×30TWLB, 30G×1/2（0.3×12.7mm）, 21G×1 1/2, 23G×1, 19G×1 1/2（1.1×32mm）, 22G×1 1/4（0.7×32mm）, 18GX1 1/2, 1208
Primary DI / UDI-DI
06945144712089
Basic UDI-DI
69451447004ZSZ8M
EMDN Code
A0101010102 Hypodermic syringe needles, w/o safety systems
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009732
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Changzhou Shuangma Medical Devices Co., Ltd

See all devices from Changzhou Shuangma Medical Devices Co., Ltd →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No