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CTM Power Chair
EUDAMEDFDA UDIClass I (EU MDR)
Ref HS-1500, Ventura, BERKO JO-30Model HS-1500
Identity
- Trade Name
- CTM Power Chair EUDAMEDCTM FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Power Chair EUDAMEDPortable Power Chair FDA UDI
- Model / Reference
- HS-1500 EUDAMEDFDA UDIHS-1500, Ventura, BERKO JO-30 EUDAMED
- Description
- Portable Power Chair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017490420 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017490HS-1500N3 EUDAMED
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled 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-1500N3 | 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 12c96d47-e0a7-4382-8ee3-40745c324a1d 61 fields · synced Jun 18, 2026
- FDA UDI ef4d54ce-49c5-4dde-8194-50f12f310c18 33 fields · synced May 30, 2026
- EUDAMED 12c96d47-e0a7-4382-8ee3-40745c324a1d-1 61 fields · synced Jun 10, 2026