Identity
- Device Name
- SPLINT ULNAR NEOPRENE EUDAMED
- Model / Reference
- 8516BEISMR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914035375 EUDAMED
- Basic UDI-DI
- 7631898516CX EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES 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
Splint Ulnar Neoprene by Elastic Therapy — 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 | 7631898516CX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED a8eab185-e9e9-469a-b448-1d8025008ffc 61 fields · synced Jun 19, 2026