Identity
- Trade Name
- Procast EUDAMED
- Model / Reference
- BU00115 EUDAMEDX0415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690977752658 EUDAMED
- Basic UDI-DI
- 5690967BU00115NB EUDAMED
- EMDN Code
- M010299 ORTHOPAEDIC WADDING - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Procast by Össur Iceland ehf. — 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 | 5690967BU00115NB | Class I | Active |
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Manufacturer
- Manufacturer
- Össur Iceland ehf.
- EUDAMED SRN
- IS-MF-000000173
Sources (1)
- EUDAMED ff67083a-168a-490e-a337-2563469bd57a 61 fields · synced Aug 4, 2026