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4SURE

by Promisemed Hangzhou Meditech Co., Ltd. China EUDAMED

Ref NPN-31*6

EMDN A0101010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697122740IPNPZ Basic UDI-DIDate22 Nov 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Insulin Pen Needles
Model / Reference
NPN-31*6
Primary DI / UDI-DI
06975965294938
Basic UDI-DI
697122740IPNPZ
Unit of Use DI
86975965294934
EMDN Code
A0101010201 Hypodermic pen needles, with safety systems
Device Class
Class IIa
Market of Registration
Belgium

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06975965294938|697122740IPNPZ 61 fields · synced 24 Oct 2026