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Mobility Scooter
EUDAMEDClass I (EU MDR)
Ref HS-658L, Orion Pro 4W, Pegasus Pro 4WModel HS-658L
Identity
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- HS-658L EUDAMEDHS-658L, Orion Pro 4W, Pegasus Pro 4W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850017490253 EUDAMED
- Basic UDI-DI
- 0850017490HS-658LRL 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-658LRL | Class I | Active |
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Manufacturer
- Manufacturer
- Chien Ti Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000001535
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 40261ef0-49c6-4d8a-8c30-64db064dd7a2 61 fields · synced Jun 19, 2026
- EUDAMED 40261ef0-49c6-4d8a-8c30-64db064dd7a2-1 61 fields · synced Jun 10, 2026