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smart visual ear cleaner
EUDAMEDClass I (EU MDR)
Ref Earsight UltraModel R1+ X3 X0 X1 Q3 D3 Pro Note5 Note5 Pro(refer to Declaration of Conformity for the complete models)
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) EUDAMEDEarsight Ultra EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972403821855 EUDAMED
- Basic UDI-DI
- 697240382earmirrorEE EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 (1)
- EUDAMED c10e130c-6b05-4620-adc0-1dc1d98e445c 61 fields · synced Jun 19, 2026