Polmil
by Jiangsu Kanghua Medical Equipment Co., Ltd. 2 variants
Ref PSM4103BFModel Middle Size Drip Chamber with ￠13.5 Air Filter, Luer Luck Connector with Cap, DEHP-free Tube, SYQ
Active
CE MDR CE MDD
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 | NumberB-06935491700143 06935491700143 | Date7 Oct 2023 | StatusActive |
| European Union | CE/MDD | NumberB-06935491700143 06935491700143 | Date7 Oct 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Disposable Infusion SetsDisposable Infusion Sets without Needle
- Model / Reference
- Middle Size Drip Chamber with ￠13.5 Air Filter, Luer Luck Connector with Cap, DEHP-free Tube, PSM4103BF, SYQ
- Primary DI / UDI-DI
- 06935491700143
- Basic UDI-DI
- B-06935491700143, 693549171100JN
- EMDN Code
- A03010103, A03010101
- Device Class
- Class IIaClass I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000033842
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangsu Kanghua Medical Equipment Co., Ltd.
See all devices from Jiangsu Kanghua Medical Equipment Co., Ltd. →
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