Nipro
by Jiangsu Caina Medical Co., Ltd. China EUDAMED
Ref PFS-5LC-SFP-SCModel PP01 series
EMDN A02010701
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69715644600340ZU | Date20 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Pre-Filled Syringe with Saline
- Model / Reference
- PP01 series, PFS-5LC-SFP-SC
- Primary DI / UDI-DI
- 05420040820652
- Basic UDI-DI
- 69715644600340ZU
- EMDN Code
- A02010701 Prefilled syringes with sterile physiological solution
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000011217
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangsu Caina Medical 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 05420040820652|69715644600340ZU