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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

Plusab Wound2Eye — Class IIa MDR by Aurena Laboratories AB

MD Atlas
Aurena Laboratories AB

EUDAMED last updated this device on Feb 18, 2025

Plusab Wound2Eye

7332343200017D

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aurena Laboratories AB
UDI-DI code: 07332343300862
Reference / catalog number: 301453

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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

9 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 temperature exceeding 50°C/122°F
CW999
Protect from sunlight.
CW999
Keep out of reach of children.
CW999
Avoid direct contact between the nozzle and the wound/eye.
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.

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Market distribution

Primary placement in Sweden; available across 2 countries total.

Country	On market since	Until
SwedenPrimary placement	Feb 18, 2025	Still on market
Finland	Feb 18, 2025	Still on market

Device identification

Trade name: Plusab Wound2Eye
UDI-DI code: 07332343300862
Basic UDI-DI: 7332343200017D
Reference / catalog number: 301453
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 2002-2 Wound and Eye Wash, Isotonic, NaCl, Buffered 50 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)07332343300862

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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.

M04040101SALINE DRESSINGS, NON-COMBINED

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.