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Elbow Brace
EUDAMEDClass I (EU MDR)
Ref UniversalModel S,M,L,XL,Universal,Left,Right
Identity
- Trade Name
- Elbow Brace EUDAMED
- Device Name
- Elbow Brace EUDAMED
- Model / Reference
- S,M,L,XL,Universal,Left,Right EUDAMEDUniversal EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979025030610 EUDAMED
- Basic UDI-DI
- 697902503ELBRA 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
Elbow Brace by Xiamen Bosegrow Medical Equipment Co., Ltd — 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 | 697902503ELBRA | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Bosegrow Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000048932
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (1)
- EUDAMED 172c24af-61b9-45b9-8198-7bbe0d876f17 61 fields · synced Jun 19, 2026