Definium Tempo
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Definium Tempo EUDAMEDDefinium FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Medical Diagnostic Radiology Device EUDAMEDDefinium Tempo System UDI FDA UDI
- Model / Reference
- Definium Tempo EUDAMEDB2401CAB EUDAMEDTempo FDA UDI
- Description
- Definium Tempo System UDI FDA UDI
Identifiers
- Catalog Number
- B2401CAB FDA UDI
- Primary DI / UDI-DI
- 00195278118356 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00192HG EUDAMED
- FDA Product Code
- KPR FDA UDIIZF FDA UDIMQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI892.1740 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Stationary basic diagnostic x-ray system, digital
Definium Tempo by GE Hualun Medical Systems Co., Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00192HG | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE HUALUN MEDICAL SYSTEMS CO. Ltd
- EUDAMED SRN
- CN-MF-000001189
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED cdfafe1b-40f8-4119-9795-1f1a9928b8eb 61 fields · synced Jul 29, 2026
- FDA UDI b3598471-1351-4050-affe-e8b3936029cd 35 fields · synced May 29, 2026