Identity
- Trade Name
- Nasal Irrigator EUDAMED
- Device Name
- Nasal Irrigator EUDAMED
- Model / Reference
- NS1A3 EUDAMEDNS2A3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927394502245 EUDAMED
- Basic UDI-DI
- 69273945NI02UY EUDAMED
- Direct Marketing DI
- 06927394502245 EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Nasal Irrigator devices are medical devices used to deliver nasal irrigation solution directly into the nasal passages, promoting healthy nasal drainage and reducing congestion. These devices come in various models, including the NS1A3, which is a Class I device according to the FDA's Center for Devices and Radiological Health.
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 | 69273945NI02UY | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012835
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fc2849bf-2a0a-46c8-97a3-b1148baa6092 61 fields · synced Oct 7, 2026