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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

JutaVit Isotonic Sea Water Nasal… — Class IIa MDR

MD Atlas
Aurena Laboratories AB

EUDAMED last updated this device on Aug 27, 2024

JutaVit Isotonic Sea Water Nasal Spray 100 ml

7332343200067P

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aurena Laboratories AB
UDI-DI code: 07332343300473
Reference / catalog number: 301418

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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 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
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 Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement	Aug 27, 2024	Still on market

Device identification

Trade name: JutaVit Isotonic Sea Water Nasal Spray 100 ml
UDI-DI code: 07332343300473
Basic UDI-DI: 7332343200067P
Reference / catalog number: 301418
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 2010-4, Nasal spray, Isotonic, Seawater solution
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

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.