← Back to catalogue
Manual wheelchair
EUDAMEDClass I (EU MDR)
Ref 318 – 23 51 Model 3001, 3002, 218-23, 218-23 WHD, 118-23, 118-23 Plus, 218-24, 108-23, Primeo, Primeo Plus, 348-23, 318-23, Relax Comfort, 358-23, 228-24 J, 538-23, 538-23 Hemi, 538-23 Comfort
Identity
- Device Name
- Manual wheelchair EUDAMED
- Model / Reference
- 3001, 3002, 218-23, 218-23 WHD, 118-23, 118-23 Plus, 218-24, 108-23, Primeo, Primeo Plus, 348-23, 318-23, Relax Comfort, 358-23, 228-24 J, 538-23, 538-23 Hemi, 538-23 Comfort EUDAMED318 – 23 51 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977868800506 EUDAMED
- Basic UDI-DI
- 697786880MwheelchairT8 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 A & I Industries Ltd Shunde Foshan — 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 | 697786880MwheelchairT8 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- A & I Industries Ltd Shunde Foshan
- EUDAMED SRN
- CN-MF-000038647
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 92d3fedd-cb03-4a55-91af-47f9894d37cf 61 fields · synced Jun 18, 2026