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Firazyr® Pediatric Administration Kit

by Takeda Pharmaceuticals U.S.A., Inc. 7 variants

Ref 5000572

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, self-declared

Class I: no certifier involved

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/MDR Number0850025688Firazyr_PackK9 Basic UDI-DI 00850025688246UDI-DIDate19 Nov 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Firazyr® Pediatric Administration Kit
Model / Reference
5000572
Primary DI / UDI-DI
00850025688246
Basic UDI-DI
0850025688Firazyr_PackK9
EMDN Code
A030499 Administration kits - other
Device Class
Class I
Medical Purpose
The Firazyr® Pediatric Administration Kit is intended to be used by a heath care professional (HCP) or caregiver to measure and extract a graduated dose of up to 3 ML of liquid drug product in preparation for subcutaneous administration to a pediatric patient.

Manufacturer details

EUDAMED SRN
US-PR-000007896

Other devices from Takeda Pharmaceuticals U.S.A., Inc.

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Properties

Other properties (1)

  • Sterile: No