EAGTY Sterile Paclitaxel-Eluting PTA Balloon Catheter
by Zhejiang Barty Medical Technology Co., Ltd. 1,000+ variants
Ref W090050008018
Active
CE MDR
Valid until
23 Jul 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69277410ZBT0006TM 06941704351057 | Date18 Aug 2026 | StatusActive |
Certificates
- MDR.2292-2026/0050 Active
Technical documentation EU MDR
- Certifier
- UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
- Issued
- 31 Jul 2026
- Expires
- 23 Jul 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile Paclitaxel-Eluting PTA Balloon Catheter
- Model / Reference
- W090050008018
- Primary DI / UDI-DI
- 06941704351057
- Basic UDI-DI
- 69277410ZBT0006TM
- EMDN Code
- C010402020101 PTA balloon dilatation catheters
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000007977
- Authorised representative
- MedPath GmbH DE-AR-000000087
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Properties
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