← Back to catalogue
Bioptimal Central Venous Catheter and Catheterization Kit
EUDAMEDClass III (EU MDR)
Ref 25-000023-38Model CVN-402-10Ref 25-000100-41Model CVN-703-30Ref 25-000017-62Model CVNR-802-20(EUROPE)Ref 25-000100-02Model CVN-703-16Ref 25-000021-67Model CVNR-804-20(EUROPE)Ref 25-000017-63Model CV-802-16Y(EUROPE)Ref 25-000017-51Model CVN-802-20(EUROPE)Ref 25-000004-63Model CV-702-20 Ref 25-000021-37Model CV-804-16Ref 25-000100-44Model CVNR-703-20Ref 25-000023-39Model CVN-402-06Ref 25-000070-18Model CVN-702-30Ref 25-000009-78Model CV-501-20YRef 25-000025-45Model CVN-502-10Ref 25-000001-85Model CVR-703-20Ref 25-000017-81Model CVN-802-20Y(CROATIA)Ref 25-000009-79Model CVN-501-16Ref 25-000021-58Model CV-804-30Y(EUROPE)Ref 25-000020-15Model CVN-804-30Ref 24-000251-08Model CVNR-713-20T(CROATIA)Ref 25-000100-12Model CVN-703-20Ref 25-000007-33Model CVN-401-16Ref 25-000004-90Model CVN-702-16Ref 25-000100-49Model CVNR-702-20(CROATIA)Ref 25-000019-76Model CVN-803-30Ref 25-000011-66Model CVNR-701-16Ref 25-000015-79Model CVN-713-20Y
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catheterization Kit EUDAMEDBioptimal Central Venous Catheter and Catherization Kit EUDAMED
- Device Name
- Central Venous Catheter and Catheterization Kit EUDAMEDCentral Venous Catheter and Catherization Kit EUDAMED
- Model / Reference
- CVN-402-10 EUDAMED25-000023-38 EUDAMEDCVN-703-30 EUDAMED25-000100-41 EUDAMEDCVNR-802-20(EUROPE) EUDAMED25-000017-62 EUDAMEDCVN-703-16 EUDAMED25-000100-02 EUDAMEDCVNR-804-20(EUROPE) EUDAMED25-000021-67 EUDAMEDCV-802-16Y(EUROPE) EUDAMED25-000017-63 EUDAMEDCVN-802-20(EUROPE) EUDAMED25-000017-51 EUDAMEDCV-702-20 EUDAMED25-000004-63 EUDAMEDCV-804-16 EUDAMED25-000021-37 EUDAMEDCVNR-703-20 EUDAMED25-000100-44 EUDAMEDCVN-402-06 EUDAMED25-000023-39 EUDAMEDCVN-702-30 EUDAMED25-000070-18 EUDAMEDCV-501-20Y EUDAMED25-000009-78 EUDAMEDCVN-502-10 EUDAMED25-000025-45 EUDAMEDCVR-703-20 EUDAMED25-000001-85 EUDAMEDCVN-802-20Y(CROATIA) EUDAMED25-000017-81 EUDAMEDCVN-501-16 EUDAMED25-000009-79 EUDAMEDCV-804-30Y(EUROPE) EUDAMED25-000021-58 EUDAMEDCVN-804-30 EUDAMED25-000020-15 EUDAMEDCVNR-713-20T(CROATIA) EUDAMED24-000251-08 EUDAMEDCVN-703-20 EUDAMED25-000100-12 EUDAMEDCVN-401-16 EUDAMED25-000007-33 EUDAMEDCVN-702-16 EUDAMED25-000004-90 EUDAMEDCVNR-702-20(CROATIA) EUDAMED25-000100-49 EUDAMEDCVN-803-30 EUDAMED25-000019-76 EUDAMEDCVNR-701-16 EUDAMED25-000011-66 EUDAMEDCVN-713-20Y EUDAMED25-000015-79 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483506527 EUDAMED08886483508002 EUDAMED08886483506084 EUDAMED08886483506800 EUDAMED08886483506428 EUDAMED08886483506091 EUDAMED08886483506039 EUDAMED08886483505506 EUDAMED08886483506312 EUDAMED08886483509986 EUDAMED08886483506534 EUDAMED08886483508019 EUDAMED08886483531420 EUDAMED08886483506619 EUDAMED08886483505384 EUDAMED08886483523784 EUDAMED08886483531451 EUDAMED08886483506367 EUDAMED08886483532007 EUDAMED08886483512542 EUDAMED08886483506855 EUDAMED08886483531437 EUDAMED08886483505568 EUDAMED08886483512573 EUDAMED08886483531994 EUDAMED08886483505889 EUDAMED08886483509672 EUDAMED
- Basic UDI-DI
- B-08886483506527 EUDAMEDB-08886483508002 EUDAMEDB-08886483506084 EUDAMEDB-08886483506800 EUDAMEDB-08886483506428 EUDAMEDB-08886483506091 EUDAMEDB-08886483506039 EUDAMEDB-08886483505506 EUDAMEDB-08886483506312 EUDAMEDB-08886483509986 EUDAMEDB-08886483506534 EUDAMEDB-08886483508019 EUDAMEDB-08886483531420 EUDAMEDB-08886483506619 EUDAMEDB-08886483505384 EUDAMEDB-08886483523784 EUDAMEDB-08886483531451 EUDAMEDB-08886483506367 EUDAMEDB-08886483532007 EUDAMEDB-08886483512542 EUDAMEDB-08886483506855 EUDAMEDB-08886483531437 EUDAMEDB-08886483505568 EUDAMEDB-08886483512573 EUDAMEDB-08886483531994 EUDAMEDB-08886483505889 EUDAMEDB-08886483509672 EUDAMED
- EMDN Code
- C01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMEDC01020203 CENTRAL VENOUS MULTI-LUMEN (>2) CATHETERS, NON-TUNNELED EUDAMEDC01020201 CENTRAL I.V. SINGLE-LUMEN 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
Category: Central venous catheterization kit, short-term
Bioptimal Central Venous Catheter and Catheterization Kit by Bioptimal International Pte. Ltd. — Class III — MDD — listed in EUDAMED
Similar devices
Also classified as Central venous catheterization kit, short-term.
- Acent-1 — Global Medikit Limited · Class III
- Centurion — Centurion Medical Products · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Cook — COOK INCORPORATED · Class II
- Shun Monitor® — Shunmei Medical Co.,Ltd · Class III
- ARROW — TELEFLEX INCORPORATED · Class II
- Medline Industries, Inc. — Centurion Medical Products · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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-08886483506527 | 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 (27)
- EUDAMED 7ac97cd9-c125-4101-aa37-f6b0598772ad 61 fields · synced Sep 18, 2026
- EUDAMED be6db22d-f3e0-435a-bf8c-b577869e7c6f 61 fields · synced May 16, 2026
- EUDAMED dfab520d-50bd-4b26-911c-469004338108 61 fields · synced May 16, 2026
- EUDAMED 4e8e0d96-b2ba-41ac-a959-c182424e3016 61 fields · synced May 16, 2026
- EUDAMED 0da2eb19-7379-44f6-965b-e404bbbf6648 61 fields · synced May 17, 2026
- EUDAMED 07f6c7a7-f82a-4c5e-bba8-78513bdc9d5d 61 fields · synced May 17, 2026
- EUDAMED 6a8a17db-5bea-4a14-862f-bf0c9c4c91c3 61 fields · synced May 17, 2026
- EUDAMED e2b5dec1-86b9-4992-9467-efbaffd73636 61 fields · synced May 17, 2026
- EUDAMED f32565f1-11f6-4d6f-9b80-16690aabe57d 61 fields · synced May 17, 2026
- EUDAMED 385f675d-9004-4f87-9cd3-3c695b01367a 61 fields · synced May 17, 2026
- EUDAMED 752ebccf-4888-4192-8017-b18509014895 61 fields · synced May 17, 2026
- EUDAMED 785b7b49-6c2d-4d22-9a11-6fbd2162913b 61 fields · synced May 17, 2026
- EUDAMED 4f0b05bf-9bb2-4a46-94ac-3f4f72b88dc8 61 fields · synced May 17, 2026
- EUDAMED 8d88155e-0843-498e-9b5e-5c68e2b1b25b 61 fields · synced May 17, 2026
- EUDAMED 352d3d21-6ddc-46dc-a448-da007bd53e2e 61 fields · synced May 17, 2026
- EUDAMED 77ed1ccf-a20a-481d-8006-1613d7aceb66 61 fields · synced May 17, 2026
- EUDAMED 9393a1bd-40b7-48eb-ace3-b0e37c8e3f78 61 fields · synced May 18, 2026
- EUDAMED 2e5eeb92-aecd-4ec6-adb0-e7d3d5f46199 61 fields · synced May 18, 2026
- EUDAMED 64e4e539-71a2-4a05-864d-0a505111f21e 61 fields · synced May 18, 2026
- EUDAMED f04cf46d-a95e-4b45-967c-d2d38be97c6e 61 fields · synced May 18, 2026
- EUDAMED 1b411dec-6eee-44fb-a519-940cd3221a66 61 fields · synced May 18, 2026
- EUDAMED f3488161-d442-43e3-af27-6777449f449a 61 fields · synced May 19, 2026
- EUDAMED e49f0ec1-8673-44f6-9e71-82752a092613 61 fields · synced May 19, 2026
- EUDAMED 785c8d45-3c14-4cd2-a4ab-73d83f8bf503 61 fields · synced May 19, 2026
- EUDAMED 88e6e692-b122-4fe9-b0c2-1ad286485da8 61 fields · synced May 19, 2026
- EUDAMED d844d4e9-472c-4895-b93a-c9746ef22f4e 61 fields · synced May 19, 2026
- EUDAMED 66132658-43bf-4347-b8d4-a6ac140a313d 61 fields · synced May 19, 2026