Sterile PTA Balloon Catheter
by Zhejiang Barty Medical Technology Co., Ltd. 352 variants
Ref H080035004035D
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69277410ZBT0003TF 06927741086015 | Date23 Oct 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- H080035004035D
- Primary DI / UDI-DI
- 06927741086015
- Basic UDI-DI
- 69277410ZBT0003TF
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class IIa
- EU 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
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