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Ear Syringes
EUDAMEDClass I (EU MDR)
Ref SA-N01Model SA-N01, SA-N02, SA-N03, SA-N04, SA-N05, SA-N06, SA-N07, SA-N08, SA-N09, SA-N10, SA-N11, SA-N12Ref SA-N02
Identity
- Device Name
- Ear Syringes EUDAMED
- Model / Reference
- SA-N01, SA-N02, SA-N03, SA-N04, SA-N05, SA-N06, SA-N07, SA-N08, SA-N09, SA-N10, SA-N11, SA-N12 EUDAMEDSA-N01 EUDAMEDSA-N02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976204590132 EUDAMED06976204590149 EUDAMED
- Basic UDI-DI
- 697620459ES01KU EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDFrance 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
Ear Syringes 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 | 697620459ES01KU | 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 (2)
- EUDAMED b59e970a-3f94-48f6-9aaa-7fb5abcdb214 61 fields · synced Jul 20, 2026
- EUDAMED ea77c23c-a3c7-4527-ab75-2f940a731ef6 61 fields · synced May 17, 2026