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Organization name
UDI-DI code
Reference / catalog number

Alvita Spray Auriculaire Nettoyant — Class IIa MDR

MD Atlas
Aurena Laboratories AB

EUDAMED last updated this device on Sep 11, 2024

Alvita Spray Auriculaire Nettoyant

7332343200097V

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aurena Laboratories AB
UDI-DI code: 07332343300503
Reference / catalog number: 301407

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View device family (Basic UDI)

Manufacturer information

Organization name: Aurena Laboratories AB
SRN: SE-MF-000002890
Manufacturer status: Active

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Albert Heijn Oorspray7332343200097VOn the market Ally® Adhesive Remover7332343200157QOn the market 3014427332343200097VOn the market Alvita Seawater Nasal Spray7332343200067POn the market 3014087332343200067POn the market

Critical warnings

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

CW999
You have a history of perforation of the ear drum.
CW999
Your ears are inflamed.
CW999
There are any foreign bodies present in the ear canal.
CW999
You are currently being treated with a tympanic drain (grommets).
CW268
EUDAMED did not publish a description for this code.
CW157
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW999
Do not expose to temperatures exceeding 50°C/122°F.
CW999
Protect from sunlight.
CW999
Keep out of reach of children.
CW999
The use of this device by more than one person may spread infections.
CW999
If symptoms persist (of ear wax) contact healthcare professionals.
CW999
If any serious incident occurs in relation to the device, report to the local competent authority and the manufacturer.

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Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Sep 10, 2024	Still on market
Spain	Sep 10, 2024	Still on market

Device identification

Trade name: Alvita Spray Auriculaire Nettoyant
UDI-DI code: 07332343300503
Basic UDI-DI: 7332343200097V
Reference / catalog number: 301407
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: REF 2013-3, Ear Spray, Isotonic, Seawater solution 100ml
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)07332343300503

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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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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.