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119123A1283043 (101 offroad Š)
EUDAMEDClass I (EU MDR)
Ref 101 offroad Š / HCT-9123A-12 Champagne colorModel HCT-9166A,HCT-9166B,HCT-9266A,HCT-9102B,HCT-9102D,HCT-9189,HCT-9102E,HCT-9226S,HCT-9137,HCT-9137A,HCT-9124,HCT-9124A,HCT-9188,HCT-9188B,HCT-9123,HCT-9210A,HCT-9210C,HCT-9201A,HCT-9201B,HCT-9201C,HCT-9201E,HCT-9291,HCT-9291B,HCT-9291C,HCT-9291D,...etc
Identity
- Trade Name
- 119123A1283043 (101 offroad Š) EUDAMED
- Device Name
- rollator EUDAMED
- Model / Reference
- HCT-9166A,HCT-9166B,HCT-9266A,HCT-9102B,HCT-9102D,HCT-9189,HCT-9102E,HCT-9226S,HCT-9137,HCT-9137A,HCT-9124,HCT-9124A,HCT-9188,HCT-9188B,HCT-9123,HCT-9210A,HCT-9210C,HCT-9201A,HCT-9201B,HCT-9201C,HCT-9201E,HCT-9291,HCT-9291B,HCT-9291C,HCT-9291D,...etc EUDAMED101 offroad Š / HCT-9123A-12 Champagne color EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973536540231 EUDAMED
- Basic UDI-DI
- 697353654rollator001XL EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
119123A1283043 (101 offroad Š) by Foshan HCT 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 | 697353654rollator001XL | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan HCT Medical Equipment Co., ltd
- EUDAMED SRN
- CN-MF-000022837
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6d14b326-3313-4627-b5a3-59c68a01d2c7 61 fields · synced Oct 7, 2026