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Pen needle

by Tianjin Huahong Technology Co., Ltd. 91 variants

Part of a family of 17 devices: see the family page

Ref NoModel Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX

Pen needle (No) is a Class IIa device made by Tianjin Huahong Technology Co., Ltd., registered in EUDAMED on 14 Oct 2025 (Basic UDI-DI 69571386PD08VB), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69571386PD08VB Basic UDI-DI 06957138615078UDI-DIDate14 Oct 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Pen needle
Model / reference
Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX, No
Primary DI / UDI-DI
06957138615078
Basic UDI-DI
69571386PD08VB
Unit of use DI
56957138615073
EMDN code
A0101010201 Hypodermic pen needles, with safety systems
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000015849
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under HYPODERMIC NEEDLES.

Other devices from Tianjin Huahong Technology Co., Ltd.

See all devices from Tianjin Huahong Technology Co., Ltd. →

Properties

  • Supplied sterile
  • Administering medicine
Other properties (12, all answered No)