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Bioptimal Thermodilution Catheter and Kits
EUDAMEDClass III (EU MDR)
Ref 21-000048-74Model TD2704NXF-EUROPERef 21-000048-31Model TD2704NX-EUROPERef 21-000055-29Model TD1704N-EUROPERef 21-000075-24Model TD1704NDX-EUROPERef 21-000009-67Model TD2604NX-EUROPERef 21-000202-01Model TD2755NDF-MERIT(EUROPE) Ref 21-000046-44Model TD2504NDXF-MERIT(EUROPE)Ref 21-000055-30Model TD1704ND-EUROPERef 21-000005-57Model TD1704NX(SP5045)-EUROPERef 21-000046-29Model TD2504NDF (110CM)-EUROPERef 21-000009-44Model TD2604NDF-EUROPERef 21-000005-93Model TD1704NXF-EUROPERef 21-000048-58Model TD2704NX-INTRARef 21-000201-24Model TD2704N(LUER)-EUROPERef 21-000201-26Model TD2704ND(SP5045)(LUER)-EUROPERef 21-000201-22Model TD2704N-EUROPERef 21-000153-30Model TD1755N-EUROPERef 21-000202-09Model TD2755N-EUROPERef 21-000046-28Model TD2504ND-EUROPERef 21-000050-42Model TD2755NX-EUROPERef 21-000202-03Model TD2755NDX-MERIT(EUROPE)Ref 21-000009-59Model TD2604NDXF-MERIT(EUROPE)Ref 21-000050-99Model TD2755NXP-EUROPERef 21-000046-56Model TD2504NF-EUROPERef 21-000104-29Model TD1604NDX-EUROPERef 21-000202-04Model TD2755NDPXF-MERIT(EUROPE)Ref 21-000104-04Model TD1604NX-EUROPERef 24-000201-11Model BIOTRAY TD2704ND(LUER)Ref 21-000151-17Model TD2602ND
Identity
- Trade Name
- Bioptimal Thermodilution Catheter and Kits EUDAMED
- Device Name
- Thermodilution Catherter and Kits EUDAMEDThermodilution Catheter and Kits EUDAMED
- Model / Reference
- TD2704NXF-EUROPE EUDAMED21-000048-74 EUDAMEDTD2704NX-EUROPE EUDAMED21-000048-31 EUDAMEDTD1704N-EUROPE EUDAMED21-000055-29 EUDAMEDTD1704NDX-EUROPE EUDAMED21-000075-24 EUDAMEDTD2604NX-EUROPE EUDAMED21-000009-67 EUDAMEDTD2755NDF-MERIT(EUROPE) EUDAMED21-000202-01 EUDAMEDTD2504NDXF-MERIT(EUROPE) EUDAMED21-000046-44 EUDAMEDTD1704ND-EUROPE EUDAMED21-000055-30 EUDAMEDTD1704NX(SP5045)-EUROPE EUDAMED21-000005-57 EUDAMEDTD2504NDF (110CM)-EUROPE EUDAMED21-000046-29 EUDAMEDTD2604NDF-EUROPE EUDAMED21-000009-44 EUDAMEDTD1704NXF-EUROPE EUDAMED21-000005-93 EUDAMEDTD2704NX-INTRA EUDAMED21-000048-58 EUDAMEDTD2704N(LUER)-EUROPE EUDAMED21-000201-24 EUDAMEDTD2704ND(SP5045)(LUER)-EUROPE EUDAMED21-000201-26 EUDAMEDTD2704N-EUROPE EUDAMED21-000201-22 EUDAMEDTD1755N-EUROPE EUDAMED21-000153-30 EUDAMEDTD2755N-EUROPE EUDAMED21-000202-09 EUDAMEDTD2504ND-EUROPE EUDAMED21-000046-28 EUDAMEDTD2755NX-EUROPE EUDAMED21-000050-42 EUDAMEDTD2755NDX-MERIT(EUROPE) EUDAMED21-000202-03 EUDAMEDTD2604NDXF-MERIT(EUROPE) EUDAMED21-000009-59 EUDAMEDTD2755NXP-EUROPE EUDAMED21-000050-99 EUDAMEDTD2504NF-EUROPE EUDAMED21-000046-56 EUDAMEDTD1604NDX-EUROPE EUDAMED21-000104-29 EUDAMEDTD2755NDPXF-MERIT(EUROPE) EUDAMED21-000202-04 EUDAMEDTD1604NX-EUROPE EUDAMED21-000104-04 EUDAMEDBIOTRAY TD2704ND(LUER) EUDAMED24-000201-11 EUDAMEDTD2602ND EUDAMED21-000151-17 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483500501 EUDAMED08886483500419 EUDAMED08886483509320 EUDAMED08886483501140 EUDAMED08886483510708 EUDAMED08886483501553 EUDAMED08886483500389 EUDAMED08886483509337 EUDAMED08886483500037 EUDAMED08886483500334 EUDAMED08886483500105 EUDAMED08886483500044 EUDAMED08886483500471 EUDAMED08886483509979 EUDAMED08886483510326 EUDAMED08886483509344 EUDAMED08886483509306 EUDAMED08886483509351 EUDAMED08886483500327 EUDAMED08886483500655 EUDAMED08886483501577 EUDAMED08886483500181 EUDAMED08886483500792 EUDAMED08886483510692 EUDAMED08886483510081 EUDAMED08886483501584 EUDAMED08886483501171 EUDAMED08886483504820 EUDAMED08886483509801 EUDAMED
- Basic UDI-DI
- B-08886483500501 EUDAMEDB-08886483500419 EUDAMEDB-08886483509320 EUDAMEDB-08886483501140 EUDAMEDB-08886483510708 EUDAMEDB-08886483501553 EUDAMEDB-08886483500389 EUDAMEDB-08886483509337 EUDAMEDB-08886483500037 EUDAMEDB-08886483500334 EUDAMEDB-08886483500105 EUDAMEDB-08886483500044 EUDAMEDB-08886483500471 EUDAMEDB-08886483509979 EUDAMEDB-08886483510326 EUDAMEDB-08886483509344 EUDAMEDB-08886483509306 EUDAMEDB-08886483509351 EUDAMEDB-08886483500327 EUDAMEDB-08886483500655 EUDAMEDB-08886483501577 EUDAMEDB-08886483500181 EUDAMEDB-08886483500792 EUDAMEDB-08886483510692 EUDAMEDB-08886483510081 EUDAMEDB-08886483501584 EUDAMEDB-08886483501171 EUDAMEDB-08886483504820 EUDAMEDB-08886483509801 EUDAMED
- EMDN Code
- C019003 THERMODILUTION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bioptimal Thermodilution Catheter and Kits by Bioptimal International Pte. Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08886483500501 | Class III | Active |
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Manufacturer
- Manufacturer
- Bioptimal International PTE. LTD.
- EUDAMED SRN
- SG-MF-000010306
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (29)
- EUDAMED 840ce777-89b3-4e8a-b8a4-74c05456ea69 61 fields · synced Sep 18, 2026
- EUDAMED 8a9151c9-5e83-490f-9b8b-d3bad31c7dcd 61 fields · synced May 16, 2026
- EUDAMED 3e14248f-8370-4b8f-9fb9-2b903d70aff0 61 fields · synced May 17, 2026
- EUDAMED 7b83530f-e802-4ee4-8854-be24f11a444e 61 fields · synced May 17, 2026
- EUDAMED 94c39a52-1e3d-4fca-bbc2-62e8c0c5fd03 61 fields · synced May 17, 2026
- EUDAMED d19e5b0c-9bc4-475b-9976-4b82a2505877 61 fields · synced May 17, 2026
- EUDAMED 2dae6847-72dc-46e3-a950-e2ab48d5f5bf 61 fields · synced May 17, 2026
- EUDAMED dae00dcd-e3c5-4eab-afae-b598eaf9d9d4 61 fields · synced May 17, 2026
- EUDAMED 227bd500-235f-4991-94e6-af6301789c76 61 fields · synced May 17, 2026
- EUDAMED 538e97e8-a151-48b4-83ba-665b2e8baca2 61 fields · synced May 17, 2026
- EUDAMED 6864db22-0a6c-4cd7-8a3c-c11cb690419b 61 fields · synced May 17, 2026
- EUDAMED d1e9c43a-e8cf-4b8a-840a-bb846edced73 61 fields · synced May 17, 2026
- EUDAMED 4bb7f378-4df0-4508-b56e-ec7685aa0666 61 fields · synced May 17, 2026
- EUDAMED 2a4e07fb-def6-40c7-82bb-ede25674236c 61 fields · synced May 18, 2026
- EUDAMED d19df841-51df-4725-9fd2-6ee67bff18e6 61 fields · synced May 18, 2026
- EUDAMED d656902e-47f6-4278-9d4b-172dbebba896 61 fields · synced May 18, 2026
- EUDAMED c76c6f0d-a43c-473f-9e7e-a87fa25a3660 61 fields · synced May 18, 2026
- EUDAMED 63b07462-d465-4f63-a79d-053150d65903 61 fields · synced May 18, 2026
- EUDAMED 792efa83-6e03-4610-b916-f7dbfd086ca3 61 fields · synced May 18, 2026
- EUDAMED ea4eae54-2c23-4770-a62c-0d4b86e6c00b 61 fields · synced May 18, 2026
- EUDAMED 410dc047-b557-4ae2-a37e-9249ad91678b 61 fields · synced May 18, 2026
- EUDAMED a298c088-eb8c-4882-94d1-ad4687535bc6 61 fields · synced May 18, 2026
- EUDAMED e0149ce6-ec5b-49f3-9ddf-1b654f62f81c 61 fields · synced May 18, 2026
- EUDAMED d137998c-7b5a-4598-a267-8fa2fdfa22ed 61 fields · synced May 18, 2026
- EUDAMED 7a2802ef-69c6-4c11-a98e-3ba6fab7ba0f 61 fields · synced May 19, 2026
- EUDAMED b2ae88d0-610e-47c4-b986-126a39f87de1 61 fields · synced May 19, 2026
- EUDAMED b4d617e5-30b1-4573-864b-481fcf65eb57 61 fields · synced May 19, 2026
- EUDAMED 216b1bd9-7e87-4966-993b-9dcbdce46c71 61 fields · synced May 19, 2026
- EUDAMED 79ae2969-d138-41f7-9193-f43616c0d47b 61 fields · synced Jul 8, 2026