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EARWAX Removal Syringe
EUDAMEDClass I (EU MDR)
Ref 20MLModel 10ml, 20ml, 30ml, 50ml, 60ml, 70ml, 80ml, 90ml, 100ml, 120ml, 125ml, 150ml, 200ml, 240ml, 250ml, 300ml, 350ml, 400ml, 450ml, 500ml, 600ml, 700ml, 800ml, 900ml, 1000ml
Identity
- Trade Name
- EARWAX Removal Syringe EUDAMED
- Device Name
- Earwax Removal Kit EUDAMED
- Model / Reference
- 10ml, 20ml, 30ml, 50ml, 60ml, 70ml, 80ml, 90ml, 100ml, 120ml, 125ml, 150ml, 200ml, 240ml, 250ml, 300ml, 350ml, 400ml, 450ml, 500ml, 600ml, 700ml, 800ml, 900ml, 1000ml EUDAMED20ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971919460500 EUDAMED
- Basic UDI-DI
- 697191946ERKV5 EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
EARWAX Removal Syringe 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 | 697191946ERKV5 | 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 b43c48c4-f60c-43d2-a5f8-153324a6db56 61 fields · synced Jun 18, 2026