Identity
- Trade Name
- KINSTRON EUDAMED
- Device Name
- Upper Limb Brace EUDAMED
- Model / Reference
- MDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978209370504 EUDAMED06978209370511 EUDAMED
- Basic UDI-DI
- 6978209372113DX EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Kinstron by Angel Sports-Medical Co., Limited — 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 | 6978209372113DX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Angel Sports-Medical Co., Limited
- EUDAMED SRN
- CN-MF-000047649
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 7e1896e3-3a1c-4e11-bc63-9e4d548f0d03 61 fields · synced Oct 6, 2026
- EUDAMED b9eff23e-473d-4588-9ebe-ada299e422c9 61 fields · synced May 19, 2026