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Manual wheelchair
EUDAMEDClass I (EU MDR)
Ref 538 - 23 Hemi 51Model 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 EUDAMED538 - 23 Hemi 51 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977868800841 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 device with detailed specifications and features.
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 |
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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 428d4a1e-dfdd-4f68-9448-3e26bc7a0b32 61 fields · synced Jul 14, 2026