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Nasal Irrigator
EUDAMEDClass I (EU MDR)
Ref SN-H06Model 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
- 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-H06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976204590064 EUDAMED
- Basic UDI-DI
- 697620459NI01L9 EUDAMED
- EMDN Code
- Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
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 67135271-a90d-4fbb-a0fa-a9f47cb064a5 61 fields · synced Jun 19, 2026