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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

LEVO01 — Class I MDD by Pharmia Oy

MD Atlas
Pharmia Oy

EUDAMED last updated this device on Nov 2, 2023

LEVO01

B-06417952243609

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Pharmia Oy
UDI-DI code: 06417952243609
Reference / catalog number: LEVO01

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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

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.

Critical warnings

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

CW011
Not for children under 2 years of age.
CW999
Do not use if you are allergic to any of the ingredients.
CW032
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06417952243609
Basic UDI-DI: B-06417952243609
Reference / catalog number: LEVO01
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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