CTM Mobility Scooter
by Chien Ti Enterprise Co., Ltd. EUDAMEDGUDID
Active
Ref HS-118, HS-118A, HS-118U, ST1, Dynamo, EvoliteModel HS-118
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0850017490HS-118LH | Date15 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00850017490024 | Date10 Dec 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- CTM Mobility Scooter EUDAMEDCtm GUDID
- Generic Name
- Assistive scooter, electric-motor-driven
- Device Name
- Mobility Scooter
- Model / Reference
- HS-118, HS-118A, HS-118U, ST1, Dynamo, Evolite
- Primary DI / UDI-DI
- 00850017490024
- Basic UDI-DI
- 0850017490HS-118LH
- FDA Product Code
- INI
- EMDN Code
- Y122124 Electric scooters
- GMDN Term
- Assistive scooter, electric-motor-driven
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 890.3800
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- TW-MF-000001535
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Chien Ti Enterprise Co., Ltd.
Properties
Other properties (23)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No