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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

Otospray — Class I MDR by Bioglan AB

MD Atlas
Bioglan AB

EUDAMED last updated this device on Nov 27, 2025

Otospray

735005784001400DR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bioglan AB
UDI-DI code: 07350057840887
Reference / catalog number: 001402

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View device family (Basic UDI)

Manufacturer information

Organization name: Bioglan AB
SRN: SE-MF-000001889
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW999
Warnings • Avoid contact with eyes and mucous membranes • Consult your doctor or pharmacist about using these preparations if you have a history of ear conditions. • There is limited experience with use during pregnancy or breastfeeding. • If the blocked feeling does not go away, you will need to visit a doctor for removal of the excess earwax.
CW999
Contra-indications OTOSPRAY is not indicated to be used by persons that have a history of ear conditions. Its use in contraindicated in infants and children under 2 years of age. The patient should consult with a doctor or pharmacist before using the product.

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Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Apr 7, 2017	Still on market
Portugal	Apr 7, 2017	Still on market

Device identification

Trade name: Otospray
UDI-DI code: 07350057840887
Basic UDI-DI: 735005784001400DR
Reference / catalog number: 001402
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: OTOSPRAY is an ear spray intended for facilitate cleaning of the external auditory canal by removing excess earwax and to prevent the formation of earwax plugs. The product is intended by the manufacturer to be used by adults and children from the age of 6 years old. When it is necessary to use it in children from 2 years of age or adults requiring a gentle spray, the use of OTOSPRAY Junior is recommended, due to the incorporation of a diffuser valve which provides a gentler spray. The spray can be used for self-administered treatment and is intended for transient use.
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)07350057840887

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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.

Q03040299EAR IRRIGATION 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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Related devices

Otospray Junior735005784001400DROn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.