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Fs
EUDAMEDClass I (EU MDR)
Ref /Model FS9634L,FS965LHF1,FS969H,FS965LH,AU965L,FS914H-1,FS913L,FS912LJ,FS9632L,,FS9636L,FS961L,FS915L
Identity
- Trade Name
- FS EUDAMED
- Device Name
- WALKING AIDS AND ACCESSORIES EUDAMED
- Model / Reference
- FS9634L,FS965LHF1,FS969H,FS965LH,AU965L,FS914H-1,FS913L,FS912LJ,FS9632L,,FS9636L,FS961L,FS915L EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938001020038 EUDAMED
- Basic UDI-DI
- 69380010003QM EUDAMED
- Direct Marketing DI
- 06938001020038 EUDAMED
- EMDN Code
- Y120699 WALKING DEVICES, TWO-HANDED OPERATION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Fs by Foshan Dongfang Medical Equipment Manufactory (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 | 69380010003QM | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Dongfang Medical Equipment Manufactory Ltd.
- EUDAMED SRN
- CN-MF-000036028
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 7cb4839e-7e48-4e04-9e09-d77067fe63ce 61 fields · synced Oct 7, 2026
- EUDAMED 2a7d17b6-fac6-4998-8d4e-58ad8665692f 61 fields · synced Oct 7, 2026