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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

301436 — Class IIa MDR by Aurena Laboratories AB

MD Atlas
Aurena Laboratories AB

EUDAMED last updated this device on Oct 10, 2024

301436

7332343200067P

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aurena Laboratories AB
UDI-DI code: 07332343300534
Reference / catalog number: 301436

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View device family (Basic UDI)

Manufacturer information

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

Critical warnings

10 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
Keep out of reach of children.
CW999
The use of this device by more than one person may spread infections.
CW999
Should be closely monitored when used for children under 6 months.
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 Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Oct 10, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07332343300534
Basic UDI-DI: 7332343200067P
Reference / catalog number: 301436
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 2010-6, Nasal spray, Ringer's solution 100 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)07332343300534

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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.

Q030103NASAL IRRIGATION SOLUTIONS

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.