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TopFine®

by Medexel Co., Ltd. 4 variants

Ref 29G(0.33mm)x12mmModel TopFine® 29G(0.33mm) x 12mm

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809445832137 Basic UDI-DI 08809445832137UDI-DIDate16 Jun 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Insullin Pen Needle
Model / Reference
TopFine® 29G(0.33mm) x 12mm, 29G(0.33mm)x12mm
Primary DI / UDI-DI
08809445832137
Basic UDI-DI
B-08809445832137
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000016654
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Medexel Co., Ltd.

See all devices from Medexel Co., Ltd. →

Properties

  • Sterile
  • Administering Medicine

Other properties (9)

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