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Rollator
EUDAMEDClass I (EU MDR)
Ref HR202Model NIP 、HR200、 HR201、 HR202、 HR203、 HR101、 HR204 、HR205、 HR206、 HR207、 HR208、 HR209、 HR210 、HR211、 HR212 、HR213
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- NIP 、HR200、 HR201、 HR202、 HR203、 HR101、 HR204 、HR205、 HR206、 HR207、 HR208、 HR209、 HR210 、HR211、 HR212 、HR213 EUDAMEDHR202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973852592020 EUDAMED
- Basic UDI-DI
- 697385259RollatorHM EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Rollator by Kunshan Hi-Fortune Health Products 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 | 697385259RollatorHM | Class I | Active |
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Manufacturer
- Manufacturer
- Kunshan Hi-Fortune Health Products Co., Ltd
- EUDAMED SRN
- CN-MF-000035403
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 35e00d5f-f2e4-4c7a-81c0-8deccac7d8ec 61 fields · synced Jun 19, 2026