Identity
- Trade Name
- CTM FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Mobility Scooter EUDAMEDMid-Range Three Wheel Mobility Scooter FDA UDI
- Model / Reference
- HS-515 EUDAMEDFDA UDIHS-515, Leo 3W EUDAMED
- Description
- Mid-Range Three Wheel Mobility Scooter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017490109 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017490HS-515LX 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
- Germany 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
Mobility Scooter by Chien Ti Enterprise Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850017490HS-515LX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 a0a133cf-6c1d-4d4f-b4ad-0ca1d6638df6 61 fields · synced Jun 18, 2026
- FDA UDI b5494747-a183-4b5e-8c39-1887554dd99e 33 fields · synced May 30, 2026
- EUDAMED a0a133cf-6c1d-4d4f-b4ad-0ca1d6638df6-1 61 fields · synced Jun 10, 2026