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Limb brace
EUDAMEDClass I (EU MDR)
Ref NS011Model ES001 ES002 ES003 ES004 ES005 ES006 ES007 HA001 HA002 HA003 HA004 KN001 KN002 KN003 KN004 KN005 KN006 KN007 KN08 KN009 KN010 KN011, etc
Identity
- Device Name
- Limb brace EUDAMED
- Model / Reference
- ES001 ES002 ES003 ES004 ES005 ES006 ES007 HA001 HA002 HA003 HA004 KN001 KN002 KN003 KN004 KN005 KN006 KN007 KN08 KN009 KN010 KN011, etc EUDAMEDNS011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816762708 EUDAMED
- Basic UDI-DI
- 697581676LB001KX EUDAMED
- EMDN Code
- Y060680 UPPER LIMB ORTHOSES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Limb brace by Xiamen Huakang Orthopedic 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 | 697581676LB001KX | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f6b8ef99-3edd-46eb-9b9d-d49447b22424 61 fields · synced Jun 18, 2026