Sterile PTCA Balloon Catheter
by Zhejiang Barty Medical Technology Co., Ltd. 109 variants
Ref PN25020
Active
CE MDR
Valid until
14 May 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberM.2025.MDR.2018 | Date22 Jun 2026 | StatusActive |
Certificates
- M.2025.MDR.2018 Active
Technical documentation EU MDR
- Certifier
- UDEM Adriatic d.o.o. 2696
- Issued
- 22 Jun 2026
- Expires
- 14 May 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- PN25020
- Primary DI / UDI-DI
- 06927741078249
- Basic UDI-DI
- 69277410ZBT0001TB
- EMDN Code
- C010401020101 Ptca balloon dilation 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