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Organization name
UDI-DI code
Reference / catalog number

LPXG01 — Class IIa MDR by Pharmia Oy

MD Atlas
Pharmia Oy

EUDAMED last updated this device on Dec 12, 2023

LPXG01

641795210002CD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pharmia Oy
UDI-DI code: 06417952244163
Reference / catalog number: LPXG01

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Manufacturer information

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

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

Critical warnings

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

CW276
When used as recommended, no adverse effects or interactions with other medicines are to be expected
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
CW262
For personal use only
CW999
Keep the product out of reach and sight of children
CW999
Avoid contact with eyes
CW999
If you have had a nasal surgery, consult a physician before using this product
CW999
Do not use the product if you are allergic to sesame oil or any other of the ingredients. 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
CW022
Do not try to enlarge the tip of the spray pump
CW010
Read the packaging leaflet before use
CW007
Do not use the product if the bottle or spray part is not intact
CW032
Do not use the product after expire date
CW277
In case of worsened or prolonged symptoms or, if you get adverse effects not mentioned in this packaging leaflet, contact a healthcare professional

Market distribution

Primary placement in Norway; available across 1 country total.

Country	On market since	Until
NorwayPrimary placement	Dec 28, 2023	Nov 30, 2027

Device identification

Trade name: not provided
UDI-DI code: 06417952244163
Basic UDI-DI: 641795210002CD
Reference / catalog number: LPXG01
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

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1183-810-22Supplemented
Quality management systemNotified body: 0537Expiry: Nov 30, 2027