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Manual Wheelchair
EUDAMEDClass I (EU MDR)
Ref SYIV100-KZ-001Model SYIV100-HTK-001 SYIV100-HTK-002 SYIV100-HTK-003 SYIV100-HTK-004 SYIV100-HTK-005 SYIV100-HTK-006 SYIV100-HTK-007 SYIV100-HTK-008 SYIV100-HTK-009 SYIV100-HTK-010 SYIV100-HTK-011 SYIV100-HTK-012 SYIV100-HTK-013 SYIV100-HTK-014 SYIV100-CSD-001 SYIV100-CSD-002
Identity
- Trade Name
- Manual Wheelchair EUDAMED
- Device Name
- Manual Wheelchair EUDAMED
- Model / Reference
- SYIV100-HTK-001 SYIV100-HTK-002 SYIV100-HTK-003 SYIV100-HTK-004 SYIV100-HTK-005 SYIV100-HTK-006 SYIV100-HTK-007 SYIV100-HTK-008 SYIV100-HTK-009 SYIV100-HTK-010 SYIV100-HTK-011 SYIV100-HTK-012 SYIV100-HTK-013 SYIV100-HTK-014 SYIV100-CSD-001 SYIV100-CSD-002 EUDAMEDSYIV100-KZ-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06980055720181 EUDAMED
- Basic UDI-DI
- 698005572MNWS9 EUDAMED
- EMDN Code
- Y122103 PUSH 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
Manual Wheelchair by Tianjin Hongyue Medical Equipment 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 | 698005572MNWS9 | Class I | Active |
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Manufacturer
- Manufacturer
- Tianjin Hongyue Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000053849
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (1)
- EUDAMED 08300f4e-8241-4800-bdf0-9ffb5d40e29d 61 fields · synced Jun 18, 2026