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Offisoins - Nasal Irrigator
EUDAMEDClass I (EU MDR)
Ref SN-H01Model SN-H01, SN-H02, SN-H03, SN-H04, SN-H05, SN-H06, SN-H07, SN-H08, SN-H09, SN-H10, SN-H11, SN-H12
Identity
- Trade Name
- OFFISOINS - NASAL IRRIGATOR EUDAMED
- Device Name
- Nasal Irrigator EUDAMED
- Model / Reference
- SN-H01, SN-H02, SN-H03, SN-H04, SN-H05, SN-H06, SN-H07, SN-H08, SN-H09, SN-H10, SN-H11, SN-H12 EUDAMEDSN-H01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976204590293 EUDAMED
- Basic UDI-DI
- 697620459NI01L9 EUDAMED
- EMDN Code
- Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Offisoins - Nasal Irrigator by Hui Zhou Suan Technology Co., Limited — Class I — 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 | 697620459NI01L9 | Class I | Active |
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Manufacturer
- Manufacturer
- Hui Zhou Suan Technology Co., Limited
- EUDAMED SRN
- CN-MF-000043037
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 64107ab0-ba5e-40e4-9012-07dcf5a309d7 61 fields · synced Jun 19, 2026