Identity
- Trade Name
- EXTENDER EUDAMED
- Device Name
- Extender Drug-Released PTA 35 LP Balloon Catheter, 5.0 mm Balloon diameter, 40 mm Balloon lenght,135cm Catheter lenght EUDAMED
- Model / Reference
- TER540L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-86814100661184J EUDAMED
- Basic UDI-DI
- B-86814100661184J 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
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- 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-86814100661184J | 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 76b9ca37-8ae9-4445-acdb-d4747ff0d5a5 61 fields · synced Sep 30, 2026