← Back to catalogue
Bioptimal Central Venous Catheter and Catherization Kit
EUDAMEDClass III (EU MDR)
Ref 25-000100-08Model CVR-703-30(EUROPE)
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catherization Kit EUDAMED
- Device Name
- Central Venous Catheter and Catherization Kit EUDAMED
- Model / Reference
- CVR-703-30(EUROPE) EUDAMED25-000100-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483506824 EUDAMED
- Basic UDI-DI
- B-08886483506824 EUDAMED
- EMDN Code
- C01020203 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
Category: Central venous catheterization kit, short-term
Bioptimal Central Venous Catheter and Catherization 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-08886483506824 | 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 (1)
- EUDAMED cbeac16e-63eb-43c8-bc62-6441411cd392 61 fields · synced Jun 18, 2026