Identity
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- HS-228 EUDAMEDHS-228, Colibri 4W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850017490048 EUDAMED
- Basic UDI-DI
- 0850017490HS-228LR EUDAMED
- EMDN Code
- Y122124 ELECTRIC SCOOTERS 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
Mobility Scooter by Chien Ti Enterprise 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 | 0850017490HS-228LR | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chien Ti Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000001535
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 301e27cd-db9a-4b0e-91d2-215b437523db 61 fields · synced Jul 31, 2026
- EUDAMED 301e27cd-db9a-4b0e-91d2-215b437523db-1 61 fields · synced Jun 10, 2026