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Splint Ulnar Neoprene
EUDAMEDClass I (EU MDR)
Ref 8516BEIMDRRef 8516BEISMLRef 8516BEIMDL
Identity
- Device Name
- SPLINT ULNAR NEOPRENE EUDAMED
- Model / Reference
- 8516BEIMDR EUDAMED8516BEISML EUDAMED8516BEIMDL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914035399 EUDAMED00885914035368 EUDAMED00885914035382 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 |
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Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (3)
- EUDAMED 7729633a-5fde-4614-bf76-29ee30343854 61 fields · synced Jul 27, 2026
- EUDAMED 53a83cee-f76c-4224-9355-17db8d133e5e 61 fields · synced May 17, 2026
- EUDAMED a548f496-6b25-476f-8186-4cec135dbe82 61 fields · synced May 18, 2026