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Biosafe

by Changzhou Tongda Medical Appliance Co., Ltd. EUDAMED

Active European Union

Ref TD-HN-1.2mmModel TD-HN

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69456320HN001K3 Basic UDI-DIDate8 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sterile Hypodermic Needles for Single Use
Model / Reference
TD-HN, TD-HN-1.2mm
Primary DI / UDI-DI
06945632025042
Basic UDI-DI
69456320HN001K3
EMDN Code
A0101010102 Hypodermic syringe needles, w/o safety systems
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000027398
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Changzhou Tongda Medical Appliance Co., Ltd.

See all devices from Changzhou Tongda Medical Appliance Co., Ltd. →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

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