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Crutch
EUDAMEDClass I (EU MDR)
Ref HK-GY010/CRModel HK-GY009/CRS,HK-GY009/CRM,HK-GY009/CRL,HK-GY009/CRXL,HK-GY010/CR,HK-GY011/CR,HK-GY012/4HA,HK-GY013/EL
Identity
- Device Name
- Crutch EUDAMED
- Model / Reference
- HK-GY009/CRS,HK-GY009/CRM,HK-GY009/CRL,HK-GY009/CRXL,HK-GY010/CR,HK-GY011/CR,HK-GY012/4HA,HK-GY013/EL EUDAMEDHK-GY010/CR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761084 EUDAMED
- Basic UDI-DI
- 697581676CrutchSN EUDAMED
- EMDN Code
- Y120303 WHITE STICKS FOR BLIND PERSONS 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
Crutch 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 | 697581676CrutchSN | 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 9aeb1f24-4a6e-4bc0-8100-18f9b490a684 61 fields · synced Oct 6, 2026