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Bioptimal Central Venous Catheter and Catherization Kit
EUDAMEDClass III (EU MDR)
Ref 25-000070-01Model CVR-702-16(EUROPE)Ref 25-000009-54Model CV-501-16(EUROPE)Ref 24-000246-08Model CV-804-20T(EUROPE)Ref 25-000021-55Model CV-804-20Y(EUROPE)Ref 25-000015-66Model CV-713-20Y(EUROPE)Ref 24-000246-16Model CVNR-804-20T(W/O CTN LABEL)（CROATIA）Ref 25-000017-72Model CVN-802-20Y(EUROPE)Ref 24-000243-27Model CVN-702-20T(EUROPE)Ref 25-000021-56Model CV-804-16Y(EUROPE)Ref 25-000019-50Model CVR-803-20(EUROPE)Ref 25-000004-88Model CV-702-30Y(EUROPE)Ref 25-000021-65Model CVN-804-16(EUROPE)Ref 25-000001-98Model CV-703-20Y(EUROPE)Ref 25-000004-62Model CV-702-16 (Europe)Ref 25-000053-02Model CV-503-30(EUROPE)Ref 25-000017-64Model CV-802-20Y(EUROPE)Ref 24-000242-24Model CVN-703-20YT(EUROPE)Ref 25-000007-21Model CV-401-20(EUROPE)Ref 25-000019-51Model CVNR-803-20(EUROPE)Ref 24-000251-04Model CVNR-713-20T(EUROPE)Ref 25-000015-57Model CVN-713-20(EUROPE)Ref 24-000242-13Model CV-703-20T (Europe)Ref 24-000242-20Model CV-703-16T(EUROPE)Ref 25-000001-99Model CV-703-30Y(EUROPE)Ref 24-000251-05Model CVNR-713-20T(W/O CTN LABEL)（CROATIA）Ref 25-000015-30Model CV-713-20 (Europe)Ref 25-000001-67Model CV-703-16 (Europe)Ref 25-000023-32Model CV-402-06(Europe)Ref 25-000021-38Model CV-804-20 (Europe)Ref 25-000001-97Model CV-703-16Y(EUROPE)Ref 25-000053-00Model CV-503-08(EUROPE)Ref 25-000015-44Model CV-713-30(EUROPE)Ref 25-000001-70Model CV-703-20E (Europe)Ref 25-000070-10Model CVNR-702-20(EUROPE)Ref 25-000011-54Model CVN-701-16Y(EUROPE)Ref 25-000004-97Model CVN-702-20E(EUROPE)Ref 24-000242-22Model CVN-703-16T(EUROPE)Ref 25-000011-47Model CV-701-16Y(EUROPE)Ref 25-000070-02Model CVR-702-30(EUROPE)Ref 25-000017-60Model CVNR-802-16(EUROPE)Ref 25-000100-09Model CVN-703-20E(EUROPE)Ref 25-000004-86Model CV-702-16Y(EUROPE)Ref 24-000243-21Model CV-702-20T(EUROPE)Ref 25-000053-09Model CVN-503-08Ref 25-000011-37Model CV-701-20 (Europe)Ref 24-000252-01Model CVNR-804-20T-SP（CROATIA）Ref 24-000242-17Model CVR-703-20T(Europe)Ref 24-000250-02Model CV-402-16T(EUROPE)Ref 24-000243-26Model CVN-702-16T(EUROPE)Ref 25-000011-61Model CVN-701-16(EUROPE)
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catherization Kit EUDAMED
- Device Name
- Central Venous Catheter and Catherization Kit EUDAMEDCentral Venous Catheter and Catheterization Kit EUDAMED
- Model / Reference
- CVR-702-16(EUROPE) EUDAMED25-000070-01 EUDAMEDCV-501-16(EUROPE) EUDAMED25-000009-54 EUDAMEDCV-804-20T(EUROPE) EUDAMED24-000246-08 EUDAMEDCV-804-20Y(EUROPE) EUDAMED25-000021-55 EUDAMEDCV-713-20Y(EUROPE) EUDAMED25-000015-66 EUDAMEDCVNR-804-20T(W/O CTN LABEL)（CROATIA） EUDAMED24-000246-16 EUDAMEDCVN-802-20Y(EUROPE) EUDAMED25-000017-72 EUDAMEDCVN-702-20T(EUROPE) EUDAMED24-000243-27 EUDAMEDCV-804-16Y(EUROPE) EUDAMED25-000021-56 EUDAMEDCVR-803-20(EUROPE) EUDAMED25-000019-50 EUDAMEDCV-702-30Y(EUROPE) EUDAMED25-000004-88 EUDAMEDCVN-804-16(EUROPE) EUDAMED25-000021-65 EUDAMEDCV-703-20Y(EUROPE) EUDAMED25-000001-98 EUDAMEDCV-702-16 (Europe) EUDAMED25-000004-62 EUDAMEDCV-503-30(EUROPE) EUDAMED25-000053-02 EUDAMEDCV-802-20Y(EUROPE) EUDAMED25-000017-64 EUDAMEDCVN-703-20YT(EUROPE) EUDAMED24-000242-24 EUDAMEDCV-401-20(EUROPE) EUDAMED25-000007-21 EUDAMEDCVNR-803-20(EUROPE) EUDAMED25-000019-51 EUDAMEDCVNR-713-20T(EUROPE) EUDAMED24-000251-04 EUDAMEDCVN-713-20(EUROPE) EUDAMED25-000015-57 EUDAMEDCV-703-20T (Europe) EUDAMED24-000242-13 EUDAMEDCV-703-16T(EUROPE) EUDAMED24-000242-20 EUDAMEDCV-703-30Y(EUROPE) EUDAMED25-000001-99 EUDAMEDCVNR-713-20T(W/O CTN LABEL)（CROATIA） EUDAMED24-000251-05 EUDAMEDCV-713-20 (Europe) EUDAMED25-000015-30 EUDAMEDCV-703-16 (Europe) EUDAMED25-000001-67 EUDAMEDCV-402-06(Europe) EUDAMED25-000023-32 EUDAMEDCV-804-20 (Europe) EUDAMED25-000021-38 EUDAMEDCV-703-16Y(EUROPE) EUDAMED25-000001-97 EUDAMEDCV-503-08(EUROPE) EUDAMED25-000053-00 EUDAMEDCV-713-30(EUROPE) EUDAMED25-000015-44 EUDAMEDCV-703-20E (Europe) EUDAMED25-000001-70 EUDAMEDCVNR-702-20(EUROPE) EUDAMED25-000070-10 EUDAMEDCVN-701-16Y(EUROPE) EUDAMED25-000011-54 EUDAMEDCVN-702-20E(EUROPE) EUDAMED25-000004-97 EUDAMEDCVN-703-16T(EUROPE) EUDAMED24-000242-22 EUDAMEDCV-701-16Y(EUROPE) EUDAMED25-000011-47 EUDAMEDCVR-702-30(EUROPE) EUDAMED25-000070-02 EUDAMEDCVNR-802-16(EUROPE) EUDAMED25-000017-60 EUDAMEDCVN-703-20E(EUROPE) EUDAMED25-000100-09 EUDAMEDCV-702-16Y(EUROPE) EUDAMED25-000004-86 EUDAMEDCV-702-20T(EUROPE) EUDAMED24-000243-21 EUDAMEDCVN-503-08 EUDAMED25-000053-09 EUDAMEDCV-701-20 (Europe) EUDAMED25-000011-37 EUDAMEDCVNR-804-20T-SP（CROATIA） EUDAMED24-000252-01 EUDAMEDCVR-703-20T(Europe) EUDAMED24-000242-17 EUDAMEDCV-402-16T(EUROPE) EUDAMED24-000250-02 EUDAMEDCVN-702-16T(EUROPE) EUDAMED24-000243-26 EUDAMEDCVN-701-16(EUROPE) EUDAMED25-000011-61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483506749 EUDAMED08886483505674 EUDAMED08886483505148 EUDAMED08886483506336 EUDAMED08886483505995 EUDAMED08886483510784 EUDAMED08886483510036 EUDAMED08886483505094 EUDAMED08886483506343 EUDAMED08886483506190 EUDAMED08886483505544 EUDAMED08886483506404 EUDAMED08886483505407 EUDAMED08886483505490 EUDAMED08886483506688 EUDAMED08886483506107 EUDAMED08886483505025 EUDAMED08886483505629 EUDAMED08886483506206 EUDAMED08886483510005 EUDAMED08886483505988 EUDAMED08886483504967 EUDAMED08886483504981 EUDAMED08886483505414 EUDAMED08886483510777 EUDAMED08886483505933 EUDAMED08886483505346 EUDAMED08886483506497 EUDAMED08886483506329 EUDAMED08886483505391 EUDAMED08886483506664 EUDAMED08886483505957 EUDAMED08886483505377 EUDAMED08886483506770 EUDAMED08886483505803 EUDAMED08886483505599 EUDAMED08886483505001 EUDAMED08886483505780 EUDAMED08886483506756 EUDAMED08886483506060 EUDAMED08886483506831 EUDAMED08886483505520 EUDAMED08886483505063 EUDAMED08886483506718 EUDAMED08886483505759 EUDAMED08886483510791 EUDAMED08886483504974 EUDAMED08886483505223 EUDAMED08886483505087 EUDAMED08886483505872 EUDAMED
- Basic UDI-DI
- B-08886483506749 EUDAMEDB-08886483505674 EUDAMEDB-08886483505148 EUDAMEDB-08886483506336 EUDAMEDB-08886483505995 EUDAMEDB-08886483510784 EUDAMEDB-08886483510036 EUDAMEDB-08886483505094 EUDAMEDB-08886483506343 EUDAMEDB-08886483506190 EUDAMEDB-08886483505544 EUDAMEDB-08886483506404 EUDAMEDB-08886483505407 EUDAMEDB-08886483505490 EUDAMEDB-08886483506688 EUDAMEDB-08886483506107 EUDAMEDB-08886483505025 EUDAMEDB-08886483505629 EUDAMEDB-08886483506206 EUDAMEDB-08886483510005 EUDAMEDB-08886483505988 EUDAMEDB-08886483504967 EUDAMEDB-08886483504981 EUDAMEDB-08886483505414 EUDAMEDB-08886483510777 EUDAMEDB-08886483505933 EUDAMEDB-08886483505346 EUDAMEDB-08886483506497 EUDAMEDB-08886483506329 EUDAMEDB-08886483505391 EUDAMEDB-08886483506664 EUDAMEDB-08886483505957 EUDAMEDB-08886483505377 EUDAMEDB-08886483506770 EUDAMEDB-08886483505803 EUDAMEDB-08886483505599 EUDAMEDB-08886483505001 EUDAMEDB-08886483505780 EUDAMEDB-08886483506756 EUDAMEDB-08886483506060 EUDAMEDB-08886483506831 EUDAMEDB-08886483505520 EUDAMEDB-08886483505063 EUDAMEDB-08886483506718 EUDAMEDB-08886483505759 EUDAMEDB-08886483510791 EUDAMEDB-08886483504974 EUDAMEDB-08886483505223 EUDAMEDB-08886483505087 EUDAMEDB-08886483505872 EUDAMED
- EMDN Code
- C01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMEDC01020201 CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED EUDAMEDC01020203 CENTRAL VENOUS MULTI-LUMEN (>2) CATHETERS, NON-TUNNELED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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 Central Venous Catheter and Catherization Kit by Bioptimal International Pte. Ltd. — Class III — MDD — listed in EUDAMED
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-08886483506749 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioptimal International PTE. LTD.
- EUDAMED SRN
- SG-MF-000010306
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (50)
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