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Trinias
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 563-79863-78510(k) K252099
Identity
- Trade Name
- Trinias EUDAMEDFDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- Digital Angiography System Trinias EUDAMED
- Model / Reference
- 563-79863-78 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217064885 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217064885 EUDAMED
- 510(k) Number
- K203535 FDA UDI
- FDA Product Code
- OWB FDA UDI
- EMDN Code
- Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES EUDAMED
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Trinias by Shimadzu Corporation — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123508 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K252099 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217064885 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 6ed7ad69-71e4-45dc-9e7b-159df1ee3c26 85 fields · synced Jun 19, 2026
- FDA UDI eac8bc5d-3872-4c00-90b0-09a7cde294ba 33 fields · synced May 30, 2026
- FDA 510(k) K123508 1 fields · synced May 18, 2026