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Electric Wheelchairs
EUDAMEDClass I (EU MDR)
Ref FR19Model FRR01, FRR02, FRR03, FRR04, FRR05, FRR06, FRR07, FRR08, FRR09, FRR10, FRR11, FRR12, FRR13, FRR14, FRR15, FRR16, FRR17, FRR18, FRR19, FRR20, FRR21, FRR22, FRR23, FRR24, FRR25
Identity
- Trade Name
- ELECTRIC WHEELCHAIRS EUDAMED
- Device Name
- ROLLATOR EUDAMED
- Model / Reference
- FRR01, FRR02, FRR03, FRR04, FRR05, FRR06, FRR07, FRR08, FRR09, FRR10, FRR11, FRR12, FRR13, FRR14, FRR15, FRR16, FRR17, FRR18, FRR19, FRR20, FRR21, FRR22, FRR23, FRR24, FRR25 EUDAMEDFR19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977599940199 EUDAMED
- Basic UDI-DI
- 697759994ROL0146 EUDAMED
- Direct Marketing DI
- 06977599940199 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Electric Wheelchairs by Suzhou Flyer Medical Technology Company Limited — 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 | 697759994ROL0146 | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Flyer Medical Technology Company Limited
- EUDAMED SRN
- CN-MF-000042599
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2b6296ec-c461-4e10-a8f8-bf2f49da4216 61 fields · synced Oct 8, 2026