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Enbrel SMARTCLIC
EUDAMEDClass IIa (EU MDR)
Ref APP-1000-05Model APP-1000Ref APP-1000-02Ref APP-1000-08
Identity
- Trade Name
- Enbrel SMARTCLIC EUDAMED
- Device Name
- Injection Device EUDAMED
- Model / Reference
- APP-1000 EUDAMEDAPP-1000-05 EUDAMEDAPP-1000-02 EUDAMEDAPP-1000-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987905000129 EUDAMED04987905000099 EUDAMED04987905000150 EUDAMED
- Basic UDI-DI
- 4987905INJECTORMJ EUDAMED
- Direct Marketing DI
- 04987905000075 EUDAMED
- EMDN Code
- Z1204021602 PORTABLE PAIN THERAPY INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
No
EUDAMED
Enbrel SMARTCLIC by Phc Corporation — 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 | 4987905INJECTORMJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- PHC Corporation
- EUDAMED SRN
- JP-MF-000008188
- Authorised Representative
- PHC Europe B.V. NL-AR-000002692
Sources (3)
- EUDAMED 1b66ce25-dfb9-4447-ad01-293384c6c83d 61 fields · synced Aug 3, 2026
- EUDAMED 61f1109c-4210-4068-abac-fde9f06cc5b7 61 fields · synced May 18, 2026
- EUDAMED 8ebf725d-01bf-4262-886a-00ec74b5b1d7 61 fields · synced May 18, 2026