Identity
- Trade Name
- Electric Nasal Irrigator EUDAMEDInhwRior FDA UDI
- Generic Name
- Nasal lavage system FDA UDI
- Device Name
- Electric Nasal Irrigator EUDAMEDElectric Nasal Irrigator: Utilizing a saline solution rinse, it helps to moisten the nasal mucosa, dilute and flush out nasal secretions, allergens, dust, and other irritants, thereby promoting the natural cleansing function of the nose and maintaining nasal comfort and patency. FDA UDI
- Model / Reference
- JQ-S14U EUDAMEDFDA UDI506 EUDAMED
- Description
- Electric Nasal Irrigator: Utilizing a saline solution rinse, it helps to moisten the nasal mucosa, dilute and flush out nasal secretions, allergens, dust, and other irritants, thereby promoting the natural cleansing function of the nose and maintaining nasal comfort and patency. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06978785665063 EUDAMEDFDA UDI
- Basic UDI-DI
- 697878566506V3 EUDAMED
- Direct Marketing DI
- 06978785665063 EUDAMED
- FDA Product Code
- KMA FDA UDI
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
- GMDN Term
- Nasal lavage system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.5550 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electric Nasal Irrigator by Shenzhen Yuechuan Trade Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697878566506V3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yuechuan trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000048151
- Authorised Representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Sources (2)
- EUDAMED 28ae48f4-c0fe-4bc4-b5c6-91ef2ac23b50 61 fields · synced Jul 19, 2026
- FDA UDI 4c4b07e3-1fc6-4430-8eb7-ba2f674bf78b 34 fields · synced May 30, 2026