EUDAMED last updated this device on Jul 27, 2026

AUDISPRAY ULTRA

B-03701510100149

On the marketClass I

Applicable legislation: —
Organization name: Coopération pharmaceutique française
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 03701510100149
Reference / catalog number: 1735207

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

AUDISPRAY ULTRA is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Coopération pharmaceutique française. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: AUDISPRAY ULTRA
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 03701510100149
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-03701510100149
Reference / catalog number: 1735207
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
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)03701510100149

EMDN nomenclature code(s)

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

Q03040299EAR IRRIGATION DEVICES - OTHER

Critical warnings

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

CONTRAINDICATIONS : Should not be used in the event of an ear infection or in general on any person who has or has had ear problems (dizziness, medical or surgical history...). Do not use, if allergic to any of the components. PRECAUTIONS FOR USE : Avoid contact especially with the ocular mucosa, if contact occurs rinse with water thoroughly. If symptoms persist, consult a doctor. AUDISPRAY ULTRA is a medical device. Any serious incident connected to use of Audispray Ultra should be reported to the manufacturer and to the competent authority of the Member State where the user lives.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Jan 1, 2015	Still on market
Portugal	Jan 1, 2015	Still on market

AUDISPRAY ULTRA

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Market distribution

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Manufacturer information

Certificates covering this device

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Certificates