EAGTY Sterile Paclitaxel-Eluting PTA Balloon Catheter
by Zhejiang Barty Medical Technology Co., Ltd. China EUDAMED
Ref W135055012035
EMDN C010402020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69277410ZBT0006TM | Date18 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 1 country, as listed in EUDAMED:
- Germany
Certificates
- MDR.2292-2026/0050 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2292
- Issued
- 31 Jul 2026
- Expires
- 23 Jul 2031
Specification
- Device Name
- Sterile Paclitaxel-Eluting PTA Balloon Catheter
- Model / Reference
- W135055012035
- Primary DI / UDI-DI
- 06941704358889
- Basic UDI-DI
- 69277410ZBT0006TM
- EMDN Code
- C010402020101 PTA balloon dilatation catheters
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000007977
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Zhejiang Barty Medical Technology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 8a34fe06-64a5-4c80-9548-c9afa52ab051