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rollator
EUDAMEDClass I (EU MDR)
Ref 9627 1.0Model 2412,2413,2416,2417,2418,2419,2420,2421,2422,2423,2424,2425,2426,9204,9205,9216,9217,9218,9219,9220, 9221,9223,9225,9226,9229,9230,9232,9234,9238,9241,9242,9243,9244,9245,9246,9269,9278,9281,9283,9284,9287,9288,9289,9290 1.0, 9290 2.0, etc
Identity
- Device Name
- rollator EUDAMED
- Model / Reference
- 2412,2413,2416,2417,2418,2419,2420,2421,2422,2423,2424,2425,2426,9204,9205,9216,9217,9218,9219,9220, 9221,9223,9225,9226,9229,9230,9232,9234,9238,9241,9242,9243,9244,9245,9246,9269,9278,9281,9283,9284,9287,9288,9289,9290 1.0, 9290 2.0, etc EUDAMED9627 1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979039860654 EUDAMED
- Basic UDI-DI
- 697903986rollator4L EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER 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
Category: Walking chair, non-foldable
rollator by Genteel Homecare Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Walking chair, non-foldable.
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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 | 697903986rollator4L | Class I | Active |
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Manufacturer
- Manufacturer
- Genteel Homecare Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000013192
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6b7b562d-b051-44f5-9090-ec581d056b96 61 fields · synced Jul 10, 2026