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119188c037084 (43160)
EUDAMEDClass I (EU MDR)
Ref 43160 / HCT-9188Model 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
- 119188C037084 (43160) 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 EUDAMED43160 / HCT-9188 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973536540323 EUDAMED
- Basic UDI-DI
- 697353654rollator001XL EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
119188c037084 (43160) 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 248bba1c-7521-46b1-9c5f-1bbd491a9262 61 fields · synced Oct 7, 2026