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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

611_0008 — Class IIa MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Dec 7, 2021

611_0008

B-06409941300363

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06409941300363
Reference / catalog number: 611_0008

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Manufacturer information

Organization name: Fysioline Oy
SRN: FI-MF-000001173
Manufacturer status: Active

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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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Käänny lääkärin puoleen, jos oireet pahenevat. Ei lasten ulottuville eikä näkyville. Vain ulkoiseen käyttöön. Ei silmiin eikä sisäiseen käyttöön. / Rådfråga läkare om symptom förvärras. Förvaras utom syn- och räckhåll för barn. Endast för utvärtes bruk. Undvik kontakt med ögon. Ej invärtes bruk.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Feb 18, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06409941300363
Basic UDI-DI: B-06409941300363
Reference / catalog number: 611_0008
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Ulkoisesti pinnallisten haavojen, naarmujen ja ihovammojen puhdistukseen sekä desinfiointiin.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 100 MU03

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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