Identity
- Device Name
- PrimeSplint EUDAMED
- Model / Reference
- 33056 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809278114110 EUDAMED
- Basic UDI-DI
- 880927811030JT 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
PrimeSplint by Prime Medical 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 | 880927811030JT | 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 ab45cb25-8a69-4da5-a861-4569546f997d 61 fields · synced Jun 18, 2026