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santecare
EUDAMEDClass I (EU MDR)
Ref HG-NI02Model HG-NI01,HG-NI02,HG-NI03,HG-NI04,HG-NI05,HG-NI06,HG-NI07,HG-NI08,HG-NI09,HG-NI10,HG-NI11, HG-NI12, HG-NI13
Identity
- Trade Name
- santecare EUDAMED
- Device Name
- Nasal Irrigator / Nasal washer / Nasal syringe / Nasal aspirator / Nasal cleaner EUDAMED
- Model / Reference
- HG-NI01,HG-NI02,HG-NI03,HG-NI04,HG-NI05,HG-NI06,HG-NI07,HG-NI08,HG-NI09,HG-NI10,HG-NI11, HG-NI12, HG-NI13 EUDAMEDHG-NI02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976543671711 EUDAMED
- Basic UDI-DI
- 697654367NI202307SD EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS 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
santecare by Hangzhou Weize Imp & Exp Co., Ltd. — 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 | 697654367NI202307SD | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Weize Imp & Exp Co., Ltd.
- EUDAMED SRN
- CN-MF-000036544
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 23518c61-5904-4533-873f-3b6d995f5cd6 61 fields · synced Jul 22, 2026