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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

LEVO09 — Class IIa MDR by Pharmia Oy

MD Atlas
Pharmia Oy

EUDAMED last updated this device on Oct 8, 2024

LEVO09

641795210001CB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pharmia Oy
UDI-DI code: 06417952244200
Reference / catalog number: LEVO09

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Manufacturer information

Organization name: Pharmia Oy
SRN: FI-MF-000001469
Manufacturer status: Active

Critical warnings

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

CW010
Read the packaging leaflet before use
CW999
Do not use the product if you are allergic to sesame oil. In case the product causes an allergic reaction, stop using the product and contact a doctor
CW999
Not for children under 2 years of age
CW007
Do not use the product if the bottle or spray part is not intact
CW277
In case of worsened or prolonged symptoms or, if you get adverse effects not mentioned in this packaging leaflet, contact a healthcare professional
CW022
Do not try to enlarge the tip of the spray pump
CW036
If you are also using other nasal sprays, it is recommended to take a break of at least one hour between using the products.
CW032
Do not use the product after expire date
CW276
When used as recommended, no adverse effects or interactions with other medicines are to be expected.
CW999
If you have had a nasal surgery, consult a physician before using this product.
CW262
For personal use only.
CW999
Avoid contact with eyes
CW999
Keep the product out of reach and sight of children.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Oct 8, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06417952244200
Basic UDI-DI: 641795210001CB
Reference / catalog number: LEVO09
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

LDER06641795210001CBOn the market LAMB03B-06417952243968On the market LMED01B-06417952243944On the market LMED07B-06417952244026On the market LMED05B-06417952243975On the market

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.