← Back to catalogue
Nasal Aspirator
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NS1Model 95195Ref NS14Ref NS13ARef NS12510(k) K090379Ref SNA15
Identity
- Trade Name
- Nasal aspirator EUDAMED
- Device Name
- Nasal Aspirator EUDAMED
- Model / Reference
- 95195 EUDAMEDNS1 EUDAMEDNS14 EUDAMEDNS13A EUDAMEDNS12 EUDAMEDSNA15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710953424254 EUDAMED04710953422250 EUDAMED04710953425558 EUDAMED04710953422236 EUDAMED04710953422205 EUDAMED04710953425886 EUDAMED
- Basic UDI-DI
- B-04710953424254 EUDAMEDB-04710953422250 EUDAMED471095342TCF05NSXMD EUDAMEDB-04710953422236 EUDAMEDB-04710953422205 EUDAMED
- Direct Marketing DI
- 04710953425558 EUDAMED04710953425886 EUDAMED
- 510(k) Number
- K090379 FDA 510(k)
- FDA Product Code
- BTA FDA 510(k)
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Market of Registration
- Italy EUDAMEDPoland EUDAMEDFrance EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nasal Aspirator by Avita Corporation — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090379 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04710953424254 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04710953424254 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AViTA Corporation
- EUDAMED SRN
- TW-MF-000010455
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (7)
- EUDAMED 9ccdce0a-d12c-483a-bb87-e7a54ba8bb38 61 fields · synced Jul 20, 2026
- EUDAMED 7f18b444-4a36-46ef-8d5a-53372b802e40 61 fields · synced May 17, 2026
- EUDAMED 725a0220-767a-4855-ac94-e8d162d98780 61 fields · synced May 17, 2026
- EUDAMED a7aff8db-846b-4e28-aa47-7c550d62ebf9 61 fields · synced May 17, 2026
- FDA 510(k) K090379 24 fields · synced May 18, 2026
- EUDAMED 350d6e87-148e-4906-9150-19b116a64221 61 fields · synced Jul 11, 2026
- EUDAMED 27a48346-249d-40c4-a626-b06ba612daa2 61 fields · synced Jul 20, 2026