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Injection Kits

by Ipsen Pharma Biotech 3 variants

Ref 1084253

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 Number358218SPPInjectionKitW7 Basic UDI-DI 03582180004018UDI-DIDate16 Jul 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Injection Kits
Model / Reference
1084253
Primary DI / UDI-DI
03582180004018
Basic UDI-DI
358218SPPInjectionKitW7
EMDN Code
A0101010101, A0101010102
Device Class
Class IIa
Medical Purpose
The Injection Kit is intended for the reconstitution and administration of the drug product

Manufacturer details

EUDAMED SRN
FR-PR-000053882

Other devices from Ipsen Pharma Biotech

Properties

Other properties (1)

  • Sterile: No