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Bioptimal Thermodilution Catheter and Kits
EUDAMEDFDA UDIClass III (EU MDR)
Ref 21-000201-15Model TD2704NXF-MERIT(EUROPE)
Identity
- Trade Name
- Bioptimal Thermodilution Catheter and Kits EUDAMEDThermodilution Catheter and Accessories FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, electrical FDA UDI
- Device Name
- Thermodilution Catherter and Kits EUDAMED
- Model / Reference
- TD2704NXF-MERIT(EUROPE) EUDAMEDFDA UDI21-000201-15 EUDAMED
Identifiers
- Catalog Number
- 21-000201-15 FDA UDI
- Primary DI / UDI-DI
- 08886483501492 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08886483501492 EUDAMED
- FDA Product Code
- DQO FDA UDI
- EMDN Code
- C019003 THERMODILUTION CATHETERS EUDAMED
- GMDN Term
- Pulmonary artery balloon catheter, electrical FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
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
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bioptimal Thermodilution Catheter and Kits by Bioptimal International Pte. Ltd. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-08886483501492 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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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 (2)
- EUDAMED 04b216cb-504c-4bac-afe9-b56bcbde9bfd 61 fields · synced Aug 4, 2026
- FDA UDI 7700d2b7-e9d6-434a-b6b3-3549190d1098 34 fields · synced May 30, 2026