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smart visual ear cleaner
EUDAMEDClass I (EU MDR)
Ref R1+Model R1+ X3 X0 X1 Q3 D3 Pro Note5 Note5 Pro(refer to Declaration of Conformity for the complete models)Ref EarSight Ultra
Identity
- Device Name
- smart visual ear cleaner EUDAMED
- Model / Reference
- R1+ X3 X0 X1 Q3 D3 Pro Note5 Note5 Pro(refer to Declaration of Conformity for the complete models) EUDAMEDR1+ EUDAMEDEarSight Ultra EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972403820018 EUDAMED06972403820100 EUDAMED
- Basic UDI-DI
- 697240382earmirrorEE EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDGermany 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
smart visual ear cleaner by Heifeng Zhizao(Shenzhen)Technology 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 | 697240382earmirrorEE | Class I | Active |
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Manufacturer
- Manufacturer
- Heifeng Zhizao(Shenzhen)Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000038425
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 6170ca05-5aaa-40d1-8940-7e09bff42ad2 61 fields · synced Jul 29, 2026
- EUDAMED 515ca748-c847-45cb-b2e5-3e65dec958b0 61 fields · synced Jul 10, 2026