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Ear Pain Relief Device
EUDAMEDClass I (EU MDR)
Ref ER812Model ER812,ER813,ER859,ER860
Identity
- Device Name
- Ear Pain Relief Device EUDAMED
- Model / Reference
- ER812,ER813,ER859,ER860 EUDAMEDER812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971919461739 EUDAMED
- Basic UDI-DI
- 697191946EPRVD EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Pain Relief Device by Ningbo Albert Novosino 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 | 697191946EPRVD | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Albert Novosino Co., Ltd.
- EUDAMED SRN
- CN-MF-000008571
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED de841a9e-7792-40a9-af8d-02c30bee7d19 61 fields · synced Jul 17, 2026