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CTM Mobility Scooter
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref HS-295, HS-295U, ValourModel HS-295510(k) K070603
Identity
- Trade Name
- CTM Mobility Scooter EUDAMEDCTM FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Mobility Scooter EUDAMEDAdvanced Mini Four Wheel Mobility Scooter FDA UDI
- Model / Reference
- HS-295 EUDAMEDFDA UDIHS-295, HS-295U, Valour EUDAMED
- Description
- Advanced Mini Four Wheel Mobility Scooter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017490062 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017490HS-295M8 EUDAMED
- FDA Product Code
- INI FDA UDI
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CTM Mobility Scooter by Chien Ti Enterprise Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K070603 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850017490HS-295M8 | Class I | Active |
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Manufacturer
- Manufacturer
- Chien Ti Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000001535
- FDA Applicant
- C.T.M. Homecare Product, Inc.
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 04221359-e9cf-475a-bc0f-22b06887fa42 85 fields · synced Jul 29, 2026
- FDA UDI cd915e35-6371-4020-ba71-14b87b5498b0 33 fields · synced May 30, 2026
- EUDAMED 04221359-e9cf-475a-bc0f-22b06887fa42-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K070603 1 fields · synced May 18, 2026