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Mobility Scooter
EUDAMEDClass I (EU MDR)
Ref HS-658, Orion Metro 4W, Pegasus Metro 4WModel HS-658
Identity
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- HS-658 EUDAMEDHS-658, Orion Metro 4W, Pegasus Metro 4W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850017490246 EUDAMED
- Basic UDI-DI
- 0850017490HS-658MN 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-658MN | 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 177b108c-4bc9-4da5-b760-907b96cd0a9a 61 fields · synced Jun 18, 2026
- EUDAMED 177b108c-4bc9-4da5-b760-907b96cd0a9a-1 61 fields · synced Jun 10, 2026