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Wrist Brace W/Enlarged Thumb Hole
EUDAMEDClass I (EU MDR)
Ref 8618BEIXSRRef 8618BEIMDRRef 8618BEILGRRef 8618BEISMR
Identity
- Device Name
- WRIST BRACE W/ENLARGED THUMB HOLE EUDAMED
- Model / Reference
- 8618BEIXSR EUDAMED8618BEIMDR EUDAMED8618BEILGR EUDAMED8618BEISMR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914033418 EUDAMED00885914033456 EUDAMED00885914033470 EUDAMED00885914033432 EUDAMED
- Basic UDI-DI
- 7631898618D8 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
Wrist Brace W/Enlarged Thumb Hole 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 | 7631898618D8 | Class I | Active |
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Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (4)
- EUDAMED 86247380-c398-4769-85cd-085867127962 61 fields · synced Aug 2, 2026
- EUDAMED 15ab1edf-a659-411e-948b-4652174faa57 61 fields · synced May 17, 2026
- EUDAMED b968a31f-7043-4932-b534-94aee9ad897a 61 fields · synced May 17, 2026
- EUDAMED 20b77388-3f19-4348-92b5-3ca7a00c172f 61 fields · synced May 18, 2026