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Bioptimal Central Venous Catheter and Catheterization Kit
EUDAMEDFDA UDIClass III (EU MDR)
Ref 24-000251-03Model CV-713-16T
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catheterization Kit EUDAMEDCentral Venous Catheter Kit FDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Device Name
- Central Venous Catheter and Catheterization Kit EUDAMED
- Model / Reference
- CV-713-16T EUDAMEDFDA UDI24-000251-03 EUDAMED
Identifiers
- Catalog Number
- 24-000251-03 FDA UDI
- Primary DI / UDI-DI
- 08886483508859 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08886483508859 EUDAMED
- FDA Product Code
- FOZ FDA UDI
- EMDN Code
- C01020203 CENTRAL VENOUS MULTI-LUMEN (>2) CATHETERS, NON-TUNNELED EUDAMED
- GMDN Term
- Central venous catheterization kit, short-term FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Market of Registration
- Greece 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
No
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 Central Venous Catheter and Catheterization Kit 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-08886483508859 | 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 f7134ced-b346-4320-abb8-8ab19d8d96a6 61 fields · synced Jul 18, 2026
- FDA UDI 58eade99-6826-424b-b383-b10fae8782ba 34 fields · synced May 30, 2026