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OtoClear Ear Irrigation Basin
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3700
by Bionix LLC
Identity
- Trade Name
- OtoClear Ear Irrigation Basin EUDAMEDBionix Development Corporation FDA UDI
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- OtoClear Basin EUDAMEDBox of 3 Ear Basins FDA UDI
- Model / Reference
- 3700 EUDAMEDFDA UDI
- Description
- Box of 3 Ear Basins FDA UDI
Identifiers
- Catalog Number
- 3700 FDA UDI
- Primary DI / UDI-DI
- 00859911004184 EUDAMEDFDA UDI
- Basic UDI-DI
- 0714646OtoClearBasinXV EUDAMED
- Unit of Use DI
- 10859911004181 EUDAMED
- FDA Product Code
- FNY FDA UDI
- EMDN Code
- A0699 DRAINAGE AND FLUID COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- General-purpose bowl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6730 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
OtoClear Ear Irrigation Basin by Bionix, LLC — 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 | 0714646OtoClearBasinXV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bionix LLC
- EUDAMED SRN
- US-MF-000020408
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 72b49de0-9196-4f18-875e-f5ebd7f562cc 61 fields · synced Jul 19, 2026
- FDA UDI 46583aec-597f-4c5a-bef8-441e1ed127c8 35 fields · synced May 29, 2026