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Definium Tempo Select
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref B4400UDIModel Definium Tempo Select
Identity
- Trade Name
- Definium Tempo Select EUDAMED
- Device Name
- Definium Tempo Select EUDAMED
- Model / Reference
- Definium Tempo Select EUDAMEDB4400UDI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953056158 EUDAMED
- Basic UDI-DI
- 08406821BUG005197E EUDAMED
- Direct Marketing DI
- 00198953056158 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Stationary basic diagnostic x-ray system, digital
Definium Tempo Select by GE Hualun Medical Systems Co., Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250788 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 08406821BUG005197E | Class IIb | Active |
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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 02945a25-b624-477a-b777-ad4f6b72d0d9 61 fields · synced Jun 19, 2026
- FDA 510(k) K250788 1 fields · synced May 18, 2026