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EAGTY Sterile Paclitaxel-Eluting PTA Balloon Catheter
EUDAMEDClass III (EU MDR)
Ref W080055025035
Identity
- Trade Name
- EAGTY Sterile Paclitaxel-Eluting PTA Balloon Catheter EUDAMED
- Device Name
- Sterile Paclitaxel-Eluting PTA Balloon Catheter EUDAMED
- Model / Reference
- W080055025035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941704356816 EUDAMED
- Basic UDI-DI
- 69277410ZBT0006TM EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Peripheral angioplasty balloon catheter, basic
EAGTY Sterile Paclitaxel-Eluting PTA Balloon Catheter by Zhejiang Barty Medical Technology Co., Ltd. — Class III — MDR — listed in EUDAMED
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- Armada — Abbott Vascular · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69277410ZBT0006TM | Class III | Active |
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Manufacturer
- Manufacturer
- Zhejiang Barty Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007977
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED beeeede7-66e5-48c4-8a51-a1e2baa17ad3 61 fields · synced Sep 17, 2026