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Isotonic Seawater Monodose
EUDAMEDClass IIa (EU MDR)
Ref TYPE D1-5mL-DosesModel Type D1/D2/D3/D4/D5/D6/D7/D8/D9/D10/D11/D12/D13/D14/D15/D16/D17/D18/D19
Identity
- Trade Name
- Isotonic Seawater Monodose EUDAMED
- Device Name
- Seawater Saline Solution (Isotonic) EUDAMED
- Model / Reference
- Type D1/D2/D3/D4/D5/D6/D7/D8/D9/D10/D11/D12/D13/D14/D15/D16/D17/D18/D19 EUDAMEDTYPE D1-5mL-Doses EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970082860424 EUDAMED
- Basic UDI-DI
- 697008286H162CY EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Isotonic Seawater Monodose by Zhuhai Ninuo Biological Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697008286H162CY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Ninuo Biological Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023308
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 4965d478-4a72-45de-b885-6c16a34dbddd 61 fields · synced Jun 18, 2026