Disposable Infusion Set with Needle
by Zhejiang Huafu Medical Equipment Co., Ltd. 4 variants
Ref /Model ISN-V
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 | Number697014550SYQ002KK 26970145505051 | Date10 May 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- Withdrawn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 Active
Specification
- Model / Reference
- ISN-V, /
- Primary DI / UDI-DI
- 26970145505051
- Basic UDI-DI
- 697014550SYQ002KK
- Unit of Use DI
- 06970145505057
- EMDN Code
- A03040199 Infusion kits (with or w/o pump), single-use - other
- Device Class
- Class IIa
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000017291
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Zhejiang Huafu Medical Equipment Co., Ltd.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No