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Ohrenspritze
EUDAMEDClass I (EU MDR)
Ref 25mlModel 8ml, 15ml, 25ml, 27ml, 30ml, 33ml, 35ml, 41ml, 55ml, 60ml, 65ml, 70ml, 75ml, 90ml, 120ml, 125ml, 135ml, 175ml, 200ml, 206ml, 205ml, 250ml, 317ml, 330ml, 490ml, 700ml, 1oz, 2oz, 3ozRef 60mlRef 75ml
Identity
- Trade Name
- OHRENSPRITZE EUDAMED
- Device Name
- Ear Syringe EUDAMED
- Model / Reference
- 8ml, 15ml, 25ml, 27ml, 30ml, 33ml, 35ml, 41ml, 55ml, 60ml, 65ml, 70ml, 75ml, 90ml, 120ml, 125ml, 135ml, 175ml, 200ml, 206ml, 205ml, 250ml, 317ml, 330ml, 490ml, 700ml, 1oz, 2oz, 3oz EUDAMED25ml EUDAMED60ml EUDAMED75ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971919461920 EUDAMED06971919461951 EUDAMED06971919461968 EUDAMED
- Basic UDI-DI
- 697191946ES4Z EUDAMED
- EMDN Code
- A020202 REUSABLE IRRIGATION SYRINGES 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
Ohrenspritze 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 | 697191946ES4Z | 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 (3)
- EUDAMED c1898a4a-eaac-487b-89c2-c0ddfd5c06a9 61 fields · synced Jul 13, 2026
- EUDAMED 9157f2b5-22e6-4efc-b2fc-134d0de1b8be 61 fields · synced May 17, 2026
- EUDAMED def24284-8469-4d94-b24a-58666a853155 61 fields · synced May 17, 2026