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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

50508 — Class I MDR by Circius Pharma AB

MD Atlas
Circius Pharma AB

EUDAMED last updated this device on Nov 21, 2025

50508

735013396Otovent1TV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Circius Pharma AB
UDI-DI code: 07350133960607
Reference / catalog number: 50508

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View device family (Basic UDI)

Manufacturer information

Organization name: Circius Pharma AB
SRN: SE-MF-000013023
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
This product contains natural rubber latex which may cause allergic reactions.

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Market distribution

Primary placement in Romania; available across 2 countries total.

Country	On market since	Until
RomaniaPrimary placement	Feb 13, 2024	Still on market
Hungary	Aug 6, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07350133960607
Basic UDI-DI: 735013396Otovent1TV
Reference / catalog number: 50508
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Otovent® is a nasal balloon device for autoinflation of the Eustachian tube to equalize negative middle ear pressure. Product contains 5 balloons and one (1) nose piece.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350133960607

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q03040199EAR DRAINAGE AND VENTILATION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

Certificate health across this manufacturer's portfolio.

28620230086Issued
Quality management systemNotified body: 2862Expiry: Nov 5, 2030