Identity
- Trade Name
- Repatha AMD EUDAMED
- Device Name
- Automated Mini-Doser EUDAMED
- Model / Reference
- AMD EUDAMED19558525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30355513003019 EUDAMED
- Basic UDI-DI
- 0355513003ZJ EUDAMED
- Direct Marketing DI
- 30355513003019 EUDAMED
- EMDN Code
- A0599 MECHANICAL INFUSION SYSTEMS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Repatha AMD by Amgen Inc. — Class IIa — 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 | 0355513003ZJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Amgen Inc.
- EUDAMED SRN
- US-MF-000001772
- Authorised Representative
- Amgen Europe B.V. NL-AR-000001405
Sources (1)
- EUDAMED 46325797-4537-4338-b288-0f5735d9e8c1 61 fields · synced Jun 19, 2026