Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- FY965L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975949519927 EUDAMED
- Basic UDI-DI
- 697594951ROLLATOR4F EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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 Foshan Feiyang Medical Equipment 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 | 697594951ROLLATOR4F | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Feiyang Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000032043
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9d7d6136-5364-4417-8d94-422fb96a921f 61 fields · synced Jun 17, 2026