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119291d41084(43172)
EUDAMEDClass I (EU MDR)
Ref 43172(HCT-9291D)Model 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
- 119291D41084(43172) 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 EUDAMED43172(HCT-9291D) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973536540521 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
119291d41084(43172) 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 0359337b-42ef-4ee2-a85f-94ecc7433d39 61 fields · synced Oct 7, 2026