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Trinias
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 563-79821-26Ref 563-79830-26Model Digital Angiography System TriniasRef 563-79821-24Ref 563-79832-24Ref 563-79820-24Ref 563-79820-26Ref 563-79840-27Ref 563-79820-25Ref 563-79831-26Ref 563-79822-24Ref 563-79831-25Ref 563-79861-08Ref 563-79831-24Ref 563-79864-97Ref 563-79832-28Ref 563-79840-24Ref 563-79864-87Ref 563-79832-25
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
- 563-79821-26 EUDAMEDDigital Angiography System Trinias EUDAMED563-79830-26 EUDAMED563-79821-24 EUDAMED563-79832-24 EUDAMED563-79820-24 EUDAMED563-79820-26 EUDAMED563-79840-27 EUDAMED563-79820-25 EUDAMED563-79831-26 EUDAMED563-79822-24 EUDAMED563-79831-25 EUDAMED563-79864-87 EUDAMEDFDA UDI563-79864-97 EUDAMEDFDA UDI563-79861-08 EUDAMEDFDA UDI563-79831-24 EUDAMED563-79832-28 EUDAMED563-79840-24 EUDAMED563-79832-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217058457 EUDAMED04540217058426 EUDAMED04540217058433 EUDAMED04540217058532 EUDAMED04540217058372 EUDAMED04540217058396 EUDAMED04540217059836 EUDAMED04540217058389 EUDAMED04540217058488 EUDAMED04540217058495 EUDAMED04540217058471 EUDAMED04540217064946 EUDAMEDFDA UDI04540217064953 EUDAMEDFDA UDI04540217066872 EUDAMEDFDA UDI04540217058464 EUDAMED04540217059829 EUDAMED04540217058563 EUDAMED04540217058549 EUDAMED
- Basic UDI-DI
- B-04540217058457 EUDAMEDB-04540217058426 EUDAMEDB-04540217058433 EUDAMEDB-04540217058532 EUDAMEDB-04540217058372 EUDAMEDB-04540217058396 EUDAMEDB-04540217059836 EUDAMEDB-04540217058389 EUDAMEDB-04540217058488 EUDAMEDB-04540217058495 EUDAMEDB-04540217058471 EUDAMEDB-04540217066872 EUDAMEDB-04540217058464 EUDAMEDB-04540217064953 EUDAMEDB-04540217059829 EUDAMEDB-04540217058563 EUDAMEDB-04540217064946 EUDAMEDB-04540217058549 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 — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04540217058457 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (21)
- EUDAMED e1a74d31-49ea-4ac8-8bba-f191438591fc 61 fields · synced Sep 18, 2026
- EUDAMED 2896c45b-1a2e-4479-83a2-9a11ea229c61 61 fields · synced May 16, 2026
- EUDAMED 0b446761-aeaa-4a26-bfc0-4d1dac2c0aeb 61 fields · synced May 16, 2026
- EUDAMED 699858c2-86c7-4541-82f9-8170669bcae3 61 fields · synced May 16, 2026
- EUDAMED b0ee3dfa-2bdc-44e4-9373-e0233b23721b 61 fields · synced May 16, 2026
- EUDAMED 96867a1b-56b9-4b81-9f9f-1a1f4338986d 61 fields · synced May 17, 2026
- EUDAMED 0c320115-169d-4777-a710-7639e3607069 61 fields · synced May 17, 2026
- EUDAMED 0dbb7167-e586-4fe1-83b8-4dc64283d56c 61 fields · synced May 18, 2026
- EUDAMED fb23022b-722f-4b4b-b0e3-a0a6134d9816 61 fields · synced May 18, 2026
- EUDAMED 6966a95e-13a7-4dc7-be3d-ba8a97b3adc9 61 fields · synced May 18, 2026
- EUDAMED 8f0421b4-582f-413d-94ce-6bdd45dab5cb 61 fields · synced May 18, 2026
- FDA UDI fdc064bc-88a0-4e7d-bbf9-e3540326dac7 33 fields · synced May 30, 2026
- FDA UDI 97b7c1e0-2aaa-4cac-9cd6-83b0b72ce8b1 33 fields · synced May 30, 2026
- FDA UDI 3ddebdf7-fc2b-4a49-848d-fef1266abbf8 33 fields · synced May 30, 2026
- EUDAMED cf50ab7e-407f-4fda-9656-4014ade3e786 61 fields · synced Jul 10, 2026
- EUDAMED 04d17ec6-ef62-44c1-afdd-381afc8b331e 61 fields · synced Jul 12, 2026
- EUDAMED 2711ca10-4115-48bb-89c4-4ab49bb7faa5 61 fields · synced Jul 21, 2026
- EUDAMED 69e43d7b-79a3-427d-a3ae-d6bccb5f7c18 61 fields · synced Jul 21, 2026
- EUDAMED d1ad39af-4547-4941-b04f-339ae58f10b2 61 fields · synced Jul 24, 2026
- EUDAMED 58f6eb1e-9bb3-4a83-9086-ed04817d948c 61 fields · synced Jul 29, 2026
- EUDAMED 3726ae1d-e650-4f00-bb09-a5e73ea4ec9a 61 fields · synced Jul 31, 2026