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Rollator
EUDAMEDClass I (EU MDR)
Ref FST935AModel FST9102、FST9103、FST9105、FST9106、FST9182、FST9183、FST9184、FST9185、FST9186、FST9187、FST9188、FST9189、FST9225、FST935A or customized
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- FST9102、FST9103、FST9105、FST9106、FST9182、FST9183、FST9184、FST9185、FST9186、FST9187、FST9188、FST9189、FST9225、FST935A or customized EUDAMEDFST935A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975845601153 EUDAMED
- Basic UDI-DI
- 697584560FST004S6 EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Zhongshan First 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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- Rollator — Caremaster Technology (HK) Group Co., Ltd · Class I
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 | 697584560FST004S6 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhongshan First Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000044385
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8afce4de-6d66-4697-b160-fb4431b5451c 61 fields · synced Jun 19, 2026