Otovent GO
Ref 57101
Otovent GO (57101) is a medical device (EU MDR Class I; EMDN category ear drainage and ventilation devices) made by Circius Pharma AB, registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 735013396OtoventGO176), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number735013396OtoventGO176 | Date15 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 735013396OtoventGO176
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 57101
- Primary DI / UDI-DI
- 07350133961321, 07350133961383
- Basic UDI-DI
- 735013396OtoventGO176
- Direct marketing DI
- 07350133961031
- EMDN code
- Q03040199 Ear drainage and ventilation devices - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- SwedenFrance
Manufacturer details
- EUDAMED SRN
- SE-MF-000013023
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