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CTM Mobility Scooter
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref HS-539, TOURER 3, ST4D 3-RadModel HS-539510(k) K181344
Identity
- Trade Name
- CTM Mobility Scooter EUDAMED
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- HS-539 EUDAMEDHS-539, TOURER 3, ST4D 3-Rad EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850017490130 EUDAMED
- Basic UDI-DI
- 0850017490HS-539MD EUDAMED
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
CTM Mobility Scooter by Chien Ti Enterprise Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162952 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K181344 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850017490HS-539MD | 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 (3)
- EUDAMED c0d269db-78e5-432f-9a5e-1469bc5a5270 85 fields · synced Jun 19, 2026
- EUDAMED c0d269db-78e5-432f-9a5e-1469bc5a5270-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K162952 1 fields · synced May 18, 2026