Organization name

Aurena Laboratories AB

SRN

SE-MF-000002890

Manufacturer status

Active

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

• If any serious incident occurs in relation to the device, report to the local competent authority and the manufacturer.

  OTHER

• H229 Pressurized container: may burst if heated
• P251 – Pressurized container: Do not pierce or burn, even after use.
• P210 – Keep away from heat/sparks/open flames/hot surfaces. — No smoking.
• Do not expose to temperatures exceeding 50°C/122°F.

  OTHER

• Seek medical attention if condition persists or gets worse.

  OTHER

• Protect from sunlight.

  OTHER

• Keep out of reach of children.

  OTHER

• Avoid direct contact between the nozzle and the wound/eye.

  OTHER

Primary placement in Austria; available across 25 countries total.

Trade name

Plum Wound and Eyewash Spray,

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07332343300176

Basic UDI-DI

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.

7332343200017D

Reference / catalog number

301350

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

2002-1, Wound and Eye Wash, Isotonic, NaCl 250 ml

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• M04040101SALINE DRESSINGS, NON-COMBINED

• Class IIa medical devices in EUDAMED

• 28620131862Issued
  Quality management systemNotified body: Intertek Medical Notified Body AB (2862)Expiry: Oct 27, 2027

Certificate health across this manufacturer's portfolio.