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Organization name
UDI-DI code
Reference / catalog number

704_0005 — Class IIa MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Dec 7, 2021

704_0005

B-06418029707505

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06418029707505
Reference / catalog number: 704_0005

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Manufacturer information

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

Critical warnings

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

CW085
Ärsyttää voimakkaasti silmiä.
CW139
Suojaa lämmöltä, kuumilta pinnoilta, kipinöiltä, avotulelta ja muilta sytytyslähteiltä. Tupakointi kielletty.
CW148
Säilytä tiiviisti suljettuna.
CW416
JOS KEMIKAALIA JOUTUU SILMIIN: Huuhdo huolellisesti vedellä usean minuutin ajan.
CW201
Poista piilolinssit, jos sen voi tehdä helposti. Jatka huuhtomista
CW057
Helposti syttyvä neste ja höyry.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Jan 31, 2007	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06418029707505
Basic UDI-DI: B-06418029707505
Reference / catalog number: 704_0005
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: Lievästi denaturoitua etanoliliuosta käytetään ei-invasiivisten lääkinnällisten laitteiden ja välineiden sekä ihon desinfiointiin ennen erilaisia toimenpiteitä. Alkoholin desinfektioaika on sen kuivumisaika.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 500 MU03

EMDN nomenclature code(s)

D0701ETHANOL FOR THE DISINFECTION OF MEDICAL DEVICES

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

800_546B-84353737087347JOn the market 800_350B-64129889131687JOn the market 704_001B-06418029707000On the market 704_010B-06418029707017On the market 704_0001B-06418029905994On 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.