Identity
- Trade Name
- SAM® Splint XL EUDAMED
- Device Name
- SAM® Splint EUDAMED
- Model / Reference
- SP508-OB-DE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00822045001114 EUDAMED
- Basic UDI-DI
- 0822045SP01US EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS 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
Category: Cotton wool roll, sterile
SAM® Splint XL by SAM Medical Products — 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 | 0822045SP01US | Class I | Active |
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Manufacturer
- Manufacturer
- SAM Medical Products
- EUDAMED SRN
- US-MF-000002589
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d47eb9fd-59d8-4a08-8a18-0cf9c357710d 61 fields · synced Jun 8, 2026