Infusion Sets for Single Use (with Needle)
by Jiangsu Zhengkang Medical Apparatus Co., Ltd. 16 variants
Ref 8104, IS-GB2Model IS-GA1,IS-GA2，IS-GB1，IS-GB2，IS-GC1，IS-GC2, Infusion Sets for Single Use (without Needle)
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 | Number695312468101FZ 06953124681041 | Date7 Sep 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- Withdrawn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
- Trade Name
- Infusion Sets for Single Use (with Needle)Infusion Sets for Single Use (without Needle)
- Model / Reference
- IS-GA1, IS-GA2，IS-GB1，IS-GB2，IS-GC1，IS-GC2, 8104, Infusion Sets for Single Use (without Needle), IS-GB2
- Primary DI / UDI-DI
- 06953124681041
- Basic UDI-DI
- 695312468101FZ, 69531246SYQ5R
- EMDN Code
- A03010101, A03010102
- Device Class
- Class IIaClass I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000037484
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangsu Zhengkang Medical Apparatus Co., Ltd.
See all devices from Jiangsu Zhengkang Medical Apparatus 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