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Electric Wheelchair
EUDAMEDClass I (EU MDR)
Ref SK-100-W04Model SK-100-W01; SK-100-W02; SK-100-W03; SK-100-W04; SK-100-W05; SK-100-W06; SK-100-W07Ref SK-100-W02Ref SK-100-W06
Identity
- Trade Name
- Electric Wheelchair EUDAMED
- Device Name
- Electric Wheelchair EUDAMED
- Model / Reference
- SK-100-W01; SK-100-W02; SK-100-W03; SK-100-W04; SK-100-W05; SK-100-W06; SK-100-W07 EUDAMEDSK-100-W04 EUDAMEDSK-100-W02 EUDAMEDSK-100-W06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979134460049 EUDAMED06979134460025 EUDAMED06979134460063 EUDAMED
- Basic UDI-DI
- 697913446SKEWU7 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS 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
Electric Wheelchair by Bazhou Shengkun Medical Device 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 | 697913446SKEWU7 | Class I | Active |
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Manufacturer
- Manufacturer
- Bazhou Shengkun Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000049634
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (3)
- EUDAMED d30626c9-14d3-42ee-8b83-84b34abf3441 61 fields · synced Jul 17, 2026
- EUDAMED a2084dde-29db-478c-9e08-b083349eec75 61 fields · synced May 18, 2026
- EUDAMED ff3dbba3-ffbb-4b0e-a979-39aec3b740d7 61 fields · synced May 18, 2026