Otaspray (Sodium Bicarbonate Ear Spray)
by Zuche Pharmaceuticals Pvt Ltd India EUDAMED
Ref SBS EMDN Q03040299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number890616753SBSSN | Date1 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sodium Bicarbonate Ear Spray
- Model / Reference
- SBS
- Primary DI / UDI-DI
- 08906167530270
- Basic UDI-DI
- 890616753SBSSN
- Direct Marketing DI
- 08906167530270
- EMDN Code
- Q03040299 Ear irrigation devices - other
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IN-MF-000010593
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Zuche Pharmaceuticals Pvt Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 6a501b65-b1bc-4a45-846c-c8de98e922a5