Identity
- Trade Name
- EXTENDER EUDAMED
- Device Name
- Extender Drug-Released PTA 14 BTK Balloon Catheter, 2.5 mm Balloon diameter, 40 mm Balloon lenght,120 cm Catheter lenght EUDAMED
- Model / Reference
- BTK2540S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8683498152929FX EUDAMED
- Basic UDI-DI
- B-8683498152929FX EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class III 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
Extender by İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.ş. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · 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-8683498152929FX | Class III | Active |
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Manufacturer
- Manufacturer
- İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.ş.
- EUDAMED SRN
- TR-MF-000019963
Sources (1)
- EUDAMED d0076ff5-71a8-4640-bfc3-df44a64bad2c 61 fields · synced Sep 30, 2026