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Ear Syringe
EUDAMEDFDA UDIClass 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, 3oz
Identity
- Trade Name
- None FDA UDI
- Generic Name
- Ear canal irrigation syringe FDA UDI
- 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 EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971919469049 EUDAMEDFDA UDI
- Basic UDI-DI
- 697191946ES4Z EUDAMED
- FDA Product Code
- KCP FDA UDI
- EMDN Code
- A020202 REUSABLE IRRIGATION SYRINGES EUDAMED
- GMDN Term
- Ear canal irrigation syringe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.5220 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ear Syringe by Ningbo Albert Novosino Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697191946ES4Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED f9aff43f-5c7b-4a1b-84df-892ced60b961 61 fields · synced Jul 31, 2026
- FDA UDI 707b014a-dbce-4396-8b00-fb4317a76dea 32 fields · synced May 29, 2026