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Bioptimal Thermodilution Catheter and Kits
EUDAMEDClass III (EU MDR)
Ref 21-000005-28Model TD1704NX-EUROPE
Identity
- Trade Name
- Bioptimal Thermodilution Catheter and Kits EUDAMED
- Device Name
- Thermodilution Catherter and Kits EUDAMED
- Model / Reference
- TD1704NX-EUROPE EUDAMED21-000005-28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483500006 EUDAMED
- Basic UDI-DI
- B-08886483500006 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
EUDAMED
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-08886483500006 | 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 (1)
- EUDAMED b0f6c600-4557-44f8-88b6-b4f599957e24 61 fields · synced Jun 18, 2026