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Wheelchair
EUDAMEDClass I (EU MDR)
Ref BME4611SModel BME4611,BME4611C,BME4611D,BME4611M,BME4611S,BME4612,BME4613,BME4614,BME4615, BME4616,BME4617,BME4618,BME4619,BME4620,BME4621,BME4622,BME4623,BME4624,BME4625,etc
Identity
- Device Name
- Wheelchair EUDAMED
- Model / Reference
- BME4611,BME4611C,BME4611D,BME4611M,BME4611S,BME4612,BME4613,BME4614,BME4615, BME4616,BME4617,BME4618,BME4619,BME4620,BME4621,BME4622,BME4623,BME4624,BME4625,etc EUDAMEDBME4611S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975126453051 EUDAMED
- Basic UDI-DI
- 697512645WheelchairD9 EUDAMED
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
Wheelchair by Shanghai Brother Medical Products Manufacturer 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 | 697512645WheelchairD9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000017485
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 16ceaf7f-4ca3-47fb-8ccc-561824faa90c 61 fields · synced Oct 7, 2026