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CTM Mobility Scooter
EUDAMEDFDA UDIClass I (EU MDR)
Ref HS-735Ref HS-118, HS-118A, HS-118U, ST1, Dynamo, EvoliteModel HS-118Ref HS-895Ref HS-745Ref HS-558Ref HS-568, Ultim8Ref HS-898, HS-898B, SPARK, ST5D, AlpineModel HS-898
Identity
- Trade Name
- CTM Mobility Scooter EUDAMEDCTM FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Mobility Scooter EUDAMEDCTM Mobility Scooter EUDAMEDTubular Four Wheel Mobility Scooter FDA UDI
- Model / Reference
- HS-735 EUDAMEDHS-118 EUDAMEDFDA UDIHS-118, HS-118A, HS-118U, ST1, Dynamo, Evolite EUDAMEDHS-895 EUDAMEDHS-745 EUDAMEDHS-558 EUDAMEDHS-568, Ultim8 EUDAMEDHS-898 EUDAMEDHS-898, HS-898B, SPARK, ST5D, Alpine EUDAMED
- Description
- Tubular Four Wheel Mobility Scooter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017490277 EUDAMED00850017490024 EUDAMEDFDA UDI00850017490376 EUDAMED00850017490291 EUDAMED00850017490147 EUDAMED00850017490642 EUDAMED00850017490383 EUDAMED
- Basic UDI-DI
- 0850017490HS-735MF EUDAMED0850017490HS-118LH EUDAMED0850017490HS-895N6 EUDAMED0850017490HS-745MJ EUDAMED0850017490HS-558MH EUDAMED0850017490HS-568ML EUDAMED0850017490HS-898NC 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 EUDAMEDGermany 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 — 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-735MF | 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 (11)
- EUDAMED aa4d36e2-7ec9-4db8-9d2b-b2212188358e 61 fields · synced Aug 1, 2026
- EUDAMED f89aafdd-eea0-454e-9d95-7493b0ff4edb 61 fields · synced May 17, 2026
- EUDAMED 4e62d455-a69c-49c0-8bc2-cad9b7b6213e 61 fields · synced May 17, 2026
- EUDAMED 5a6d42d0-dd2e-433f-9129-23b5d6122bb5 61 fields · synced May 18, 2026
- EUDAMED 73d0cfae-0bb1-4c5e-9204-67852f39b01d 61 fields · synced May 18, 2026
- FDA UDI 4b75b985-e3d0-4282-b962-c315de610f74 33 fields · synced May 29, 2026
- EUDAMED f89aafdd-eea0-454e-9d95-7493b0ff4edb-1 61 fields · synced Jun 10, 2026
- EUDAMED 708c05eb-8823-487a-82b4-7efed319513f-1 61 fields · synced Jul 15, 2026
- EUDAMED 708c05eb-8823-487a-82b4-7efed319513f-2 61 fields · synced Jul 15, 2026
- EUDAMED f281ed22-bc7c-4ffc-bc9c-998aa0ad8aea-1 61 fields · synced Aug 1, 2026
- EUDAMED f281ed22-bc7c-4ffc-bc9c-998aa0ad8aea-2 61 fields · synced Aug 1, 2026