Seawater Saline Solution (Isotonic)
by Zhuhai Ninuo Biological Technology Co., Ltd. 2 variants
Ref TYPE D10-1000mL-Irrigation SolutionModel Type D1/D2/D3/D4/D5/D6/D7/D8/D9/D10/D11/D12/D13/D14/D15/D16/D17/D18/D19
Active
CE MDR
Valid until
12 Feb 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN25/00005549 | Date2 Mar 2026 | StatusActive |
Certificates
- CN25/00005549 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 2 Mar 2026
- Expires
- 12 Feb 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Seawater Saline Solution (Isotonic)
- Model / Reference
- Type D1/D2/D3/D4/D5/D6/D7/D8/D9/D10/D11/D12/D13/D14/D15/D16/D17/D18/D19, TYPE D10-1000mL-Irrigation Solution
- Primary DI / UDI-DI
- 06970082861902
- Basic UDI-DI
- 697008286H162CY
- EMDN Code
- Q030103 Nasal irrigation solutions
- Device Class
- Class IIa
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000023308
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Other devices from Zhuhai Ninuo Biological Technology Co., Ltd.
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Properties
Other properties (13)
- Sterile: No
- 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