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3, 0 X 100 mm VeniFlow 0.014” PTA Balloon Dilatation Catheter (80 cm)
EUDAMEDClass IIa (EU MDR)
Ref VFL14300100-80Model Percutaneous Transluminal Angıoplasty (Pta) Dilatation CathetersRef VFL14300100-100
by Alfatip Ki̇mya Kozmeti̇k Tibbi̇ Malz. San. Ve Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- 3,0 X 100 mm VeniFlow 0.014” PTA Balloon Dilatation Catheter (80 cm) EUDAMED3,0 X 100 mm VeniFlow 0.014” PTA Balloon Dilatation Catheter (100 cm) EUDAMED
- Device Name
- 3,0 X 100 mm VeniFlow 0.014” PTA Balloon Dilatation Catheter (80 cm) EUDAMED3,0 X 100 mm VeniFlow 0.014” PTA Balloon Dilatation Catheter (100 cm) EUDAMED
- Model / Reference
- Percutaneous Transluminal Angıoplasty (Pta) Dilatation Catheters EUDAMEDVFL14300100-80 EUDAMEDVFL14300100-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683851831720 EUDAMED08683851832185 EUDAMED
- Basic UDI-DI
- B-08683851831720 EUDAMEDB-08683851832185 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Peripheral angioplasty balloon catheter, basic
3, 0 X 100 mm VeniFlow 0.014” PTA Balloon Dilatation Catheter (80 cm) by Alfatip Ki̇mya Kozmeti̇k Tibbi̇ Malz. San. Ve Ti̇c. Ltd. Şti̇. — Class IIa — MDD…
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
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- Senri — KANEKA Corporation · Class IIa
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- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Simpass — Simeks Tibbi Urunler San. ve Tic LTD STI · Class IIa
- Metacross OTW — KANEKA Corporation · Class IIa
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-08683851831720 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000040075
Sources (2)
- EUDAMED 3a522d7d-5edd-4054-9d14-75c4b3450399 61 fields · synced Oct 6, 2026
- EUDAMED a1fb3e61-2e73-4197-8798-8ece1d78c944 61 fields · synced May 18, 2026