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Verifine

by Promisemed Hangzhou Meditech Co., Ltd. 6 variants

Ref SPN-29-6

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697122740SPNRK Basic UDI-DI 06971227400109UDI-DIDate23 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06971227400109 UDI-DI Date25 Dec 2017ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Verifine EUDAMED
Verifine® Safety Type Insulin Pen Needle GUDID
Generic Name
Autoinjector needle
Device Name
safety pen needle
Model / Reference
SPN-29-6
Primary DI / UDI-DI
06971227400109 EUDAMED
36971227400100 GUDID
Basic UDI-DI
697122740SPNRK
Unit of Use DI
86971227400105
EMDN Code
A0101010201 Hypodermic pen needles, with safety systems
GMDN Term
Autoinjector needle
Device Class
Class IIa
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06971227400109
GUDID
36971227400100

Manufacturer details

EUDAMED SRN
CN-MF-000008465
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Promisemed Hangzhou Meditech Co., Ltd.

See all devices from Promisemed Hangzhou Meditech Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No