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Rollator
EUDAMEDClass I (EU MDR)
Ref MT-8151Model MT-8151, HFK-9210KDB-3, HFK-9219B, HFK-9236T4, HFK-9240B, HFK-9240B-1, YF-9006A, YF-9008A, YF-9008C, YF-9008E, YF-9008F, HFK-9210KD-3, KLD-9212, KLD-9218-10, YF-9007A, YF-9007B, YF-9007D, YF-9007E, YF-9007F, YF-9007C, HFK-9269KD
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- MT-8151, HFK-9210KDB-3, HFK-9219B, HFK-9236T4, HFK-9240B, HFK-9240B-1, YF-9006A, YF-9008A, YF-9008C, YF-9008E, YF-9008F, HFK-9210KD-3, KLD-9212, KLD-9218-10, YF-9007A, YF-9007B, YF-9007D, YF-9007E, YF-9007F, YF-9007C, HFK-9269KD EUDAMEDMT-8151 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979206690091 EUDAMED
- Basic UDI-DI
- 697920669RollatorGZ 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 Fuzhoujiejielemaoyiyouxiangongsi — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Walking chair, non-foldable.
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- WALKER — CHANGSHA ANWEI ELECTRONIC COMMERCE CO., LTD. · Class I
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- trio B Gehwagen — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KG · Class I
- Trionic Veloped 12er L — Trionic Sverige AB · 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 | 697920669RollatorGZ | Class I | Active |
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Manufacturer
- Manufacturer
- Fuzhoujiejielemaoyiyouxiangongsi
- EUDAMED SRN
- CN-MF-000049702
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2b1da0d0-a8cc-416c-bae0-2c38a25b2775 61 fields · synced Jun 18, 2026