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Splint Collum
EUDAMEDClass I (EU MDR)
Ref 8529BEILGRRef 8529BEISMLRef 8529BEIMDL
Identity
- Device Name
- SPLINT COLLUM EUDAMED
- Model / Reference
- 8529BEILGR EUDAMED8529BEISML EUDAMED8529BEIMDL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00600792000785 EUDAMED00600792000730 EUDAMED00600792000754 EUDAMED
- Basic UDI-DI
- 7631898529D8 EUDAMED
- EMDN Code
- Y060603 FINGERS 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 Collum 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 | 7631898529D8 | 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 cda69db3-7e4a-43d6-9688-4dd801d24b0c 61 fields · synced Aug 2, 2026
- EUDAMED 6068514c-61f6-4eb4-99e2-1ad9e8c78dd6 61 fields · synced May 17, 2026
- EUDAMED e91d789e-a760-4d2c-868f-570a0e41a461 61 fields · synced May 18, 2026