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controlfine

by Promisemed Hangzhou Meditech Co., Ltd. 9 variants

Ref IPN33*4

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 Number697122740IPNPZ Basic UDI-DI 06975965290350UDI-DIDate22 Nov 2021RegisteredStatusActive

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  • Withdrawn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

Device Name
Insulin Pen Needles
Model / Reference
IPN33*4
Primary DI / UDI-DI
06975965290350
Basic UDI-DI
697122740IPNPZ
Unit of Use DI
86975965290356
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
EU market of registration
Sweden

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
  • 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