PINECY® Inflation Device for Balloon Catheters
by Princeton Medical Scientific Co., Ltd China EUDAMED
Ref FA10002 EMDN V901699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN26/00000404 | Date16 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CN26/00000404 Issued
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 16 Jan 2026
- Expires
- 16 Jan 2031
Specification
- Model / Reference
- FA10002
- Primary DI / UDI-DI
- 06935456210328
- Basic UDI-DI
- 69354562PLYL10XC
- Direct Marketing DI
- 06935456210328
- EMDN Code
- V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000018402
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Princeton Medical Scientific Co., Ltd
See all devices from Princeton Medical Scientific Co., Ltd →
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 1647b4bc-dab5-4a5a-b9f5-407ddd111b0a