Identity
- Device Name
- Wheelchair EUDAMED
- Model / Reference
- DROMOS EUDAMED201 EUDAMEDCity EUDAMED101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16977584972010 EUDAMED16977584971013 EUDAMED
- Basic UDI-DI
- 697758497DROMOS8V EUDAMED697758497City8U EUDAMED
- Direct Marketing DI
- 16977584972010 EUDAMED16977584971013 EUDAMED
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Kunshan Agui Mechanical Appliances 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 | 697758497DROMOS8V | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kunshan Agui Mechanical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000042713
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 66bf0a93-1c08-4e1e-b463-054092a5ec7f 61 fields · synced Jul 30, 2026
- EUDAMED aa5b5532-4f7b-4c7b-bf5b-4779208ea228 61 fields · synced May 17, 2026