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rollator
EUDAMEDClass I (EU MDR)
Ref GMS-NHDR08 D-MModel GMS-NHDR08 D-M、GMS-NHDR108A-E、GMS-NHDR208A-E、GMS-NHDR308A-E、GMS-NHDR408A-E、GMS-NHDR508A-E、GMS-NHDR608A-E、GMS-NHDR708A-E、GMS-NHDR808A-E、GMS-NHDR908A-E
Identity
- Device Name
- rollator EUDAMED
- Model / Reference
- GMS-NHDR08 D-M、GMS-NHDR108A-E、GMS-NHDR208A-E、GMS-NHDR308A-E、GMS-NHDR408A-E、GMS-NHDR508A-E、GMS-NHDR608A-E、GMS-NHDR708A-E、GMS-NHDR808A-E、GMS-NHDR908A-E EUDAMEDGMS-NHDR08 D-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978707940001 EUDAMED
- Basic UDI-DI
- 697870794rollator001EA 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 Foshan Kaiyufeng Trading 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 | 697870794rollator001EA | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Kaiyufeng Trading Co., Ltd
- EUDAMED SRN
- CN-MF-000047897
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 71189762-305d-46f1-8323-afc523c1df32 61 fields · synced Jun 19, 2026