Definium Pace Select ET
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Definium Pace Select ET EUDAMEDDefinium FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Definium Pace Select ET EUDAMEDDefinium Pace Select ET System UDI FDA UDI
- Model / Reference
- Definium Pace Select ET EUDAMEDB4600UDI EUDAMEDB2600UDI EUDAMEDPace Select ET FDA UDI
- Description
- Definium Pace Select ET System UDI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00198953056103 EUDAMED00195278913807 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG005206X EUDAMED
- Direct Marketing DI
- 00198953056103 EUDAMED00195278913807 EUDAMED
- 510(k) Number
- K242678 FDA UDI
- FDA Product Code
- MQB FDA UDIKPR 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 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 Pace Select ET by GE Hualun Medical Systems Co., Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231892 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K242678 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 08406821BUG005206X | 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 (4)
- EUDAMED e818eb79-16ed-470f-9d28-4e4d2d231ebd 61 fields · synced Aug 1, 2026
- EUDAMED db4d2bcc-08a2-4043-b414-e5dd1657597e 61 fields · synced May 18, 2026
- FDA UDI 5d36ead6-cb89-4d7a-998b-b971142aa160 34 fields · synced May 29, 2026
- FDA 510(k) K231892 1 fields · synced May 18, 2026