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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

PRO®MERA EYE WASH — Class IIa MDR by Aurena Laboratories AB

MD Atlas
Aurena Laboratories AB

EUDAMED last updated this device on Jul 4, 2024

PRO®MERA EYE WASH

7332343200027F

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aurena Laboratories AB
UDI-DI code: 07332343300244
Reference / catalog number: 301406

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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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Critical warnings

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

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
Seek medical attention if condition persists or gets worse.
CW999
If any serious incident occurs in relation to the device, report to the local competent authority and the manufacturer.
CW135
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Sweden; available across 2 countries total.

Country	On market since	Until
SwedenPrimary placement	Mar 6, 2024	Still on market
Finland	Mar 6, 2024	Still on market

Device identification

Trade name: PRO®MERA EYE WASH
UDI-DI code: 07332343300244
Basic UDI-DI: 7332343200027F
Reference / catalog number: 301406
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 2003-2 Eye Wash 250 ml
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)07332343300244

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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.

Q0299OPHTHALMIC 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.