Identity
- Device Name
- Firazyr® Pediatric Administration Kit EUDAMED
- Model / Reference
- 5000570 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025688222 EUDAMED
- Basic UDI-DI
- 0850025688Firazyr_PackK9 EUDAMED
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- 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. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Firazyr® Pediatric Administration Kit by Takeda Pharmaceuticals U.S.A., Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850025688Firazyr_PackK9 | Class I | Active |
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Manufacturer
- Manufacturer
- Takeda Pharmaceuticals U.S.A., Inc.
- EUDAMED SRN
- US-PR-000007896
Sources (1)
- EUDAMED 24509a93-03c7-430d-b8fb-defd8fba14e8 61 fields · synced Jun 18, 2026