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CTM Power Chair
EUDAMEDFDA UDIClass I (EU MDR)
Ref HS-5600, B-4220 XModel HS-5600
Identity
- Trade Name
- CTM Power Chair EUDAMEDCTM FDA UDI
- Generic Name
- Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible FDA UDI
- Device Name
- Power Chair EUDAMEDHeavy Duty Rear-Wheel Drive Power Chair FDA UDI
- Model / Reference
- HS-5600 EUDAMEDFDA UDIHS-5600, B-4220 X EUDAMED
- Description
- Heavy Duty Rear-Wheel Drive Power Chair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017490451 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017490HS-5600P4 EUDAMED
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Hungary 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 Power Chair 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-5600P4 | 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 f6c0b27b-8fcb-4c17-90b4-224309ae5fac 61 fields · synced Jun 18, 2026
- FDA UDI 367ce167-27fa-425e-9e96-d81fb71d3936 33 fields · synced May 30, 2026
- EUDAMED f6c0b27b-8fcb-4c17-90b4-224309ae5fac-1 61 fields · synced Jun 10, 2026