Identity
- Device Name
- PrimeCast EUDAMED
- Model / Reference
- 33056 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809278110150 EUDAMED
- Basic UDI-DI
- 880927811010JM EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Cotton wool roll, sterile
PrimeCast by Prime Medical Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 880927811010JM | Class I | Active |
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Manufacturer
- Manufacturer
- Prime Medical Inc.
- EUDAMED SRN
- KR-MF-000038006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED e85ec122-5f77-4211-b7d1-437d7f59a414 61 fields · synced Jul 11, 2026