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Walker
EUDAMEDClass I (EU MDR)
Ref FHZ964L-5 Model FHZ913L, FHZ913L(S), FHZ962L, FHZ9632L, FHZ961L, FHZ915L, FHZ919L, FHZ965L, FHZ966L(S), FHZ912L-5”, FHZ912L-2.5”, FHZ914L, FHZ914L（2）, FHZ918L, FHZ966L(S)-2.5”, FHZ964L-5, FHZ964L, FHZ917L, FHZ9124L
Identity
- Device Name
- Walker EUDAMED
- Model / Reference
- FHZ913L, FHZ913L(S), FHZ962L, FHZ9632L, FHZ961L, FHZ915L, FHZ919L, FHZ965L, FHZ966L(S), FHZ912L-5”, FHZ912L-2.5”, FHZ914L, FHZ914L（2）, FHZ918L, FHZ966L(S)-2.5”, FHZ964L-5, FHZ964L, FHZ917L, FHZ9124L EUDAMEDFHZ964L-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974827544259 EUDAMED
- Basic UDI-DI
- 697482754WalkerQL EUDAMED
- EMDN Code
- Y120603 WALKING FRAMES, 4 TIPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Walker by Tousda medical technology co.，Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697482754WalkerQL | Class I | Active |
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Manufacturer
- Manufacturer
- Tousda medical technology co.，Ltd.
- EUDAMED SRN
- CN-MF-000013156
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a91227ac-2369-446d-abf8-f3eeb09f25ba 61 fields · synced Jun 19, 2026