Identity
- Device Name
- WRIST BRACE D-RING W/SPICA EUDAMED
- Model / Reference
- 8513BEIXSR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914033739 EUDAMED
- Basic UDI-DI
- 7631898513CR EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-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
Wrist Brace D-Ring W/Spica 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 | 7631898513CR | Class I | Active |
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Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 8d501f9d-8502-45c3-93cc-26c9627ab4ab 61 fields · synced Jun 19, 2026