Identity
- Trade Name
- OtoClear SprayWash EUDAMEDOtoClear® Spray Wash Kit FDA UDI
- Generic Name
- Ear canal irrigation kit, reusable FDA UDI
- Device Name
- OtoClear EUDAMEDSprayWash Bottle FDA UDI
- Model / Reference
- 7295 EUDAMEDFDA UDI
- Description
- SprayWash Bottle FDA UDI
Identifiers
- Catalog Number
- 7295 FDA UDI
- Primary DI / UDI-DI
- 00859911004290 EUDAMEDFDA UDI
- Basic UDI-DI
- 859911004OtoClearNE EUDAMED
- FDA Product Code
- LRD FDA UDI
- EMDN Code
- Z12149099 VARIOUS ENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ear canal irrigation kit, reusable 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 SprayWash 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 | 859911004OtoClearNE | 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 8d14f473-d23b-4c7c-8e44-f346776c6edd 61 fields · synced May 30, 2026
- FDA UDI cc2b9d14-deb0-4c95-a1f5-34a680285fa5 35 fields · synced May 30, 2026