Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

611_0002 — Class IIa MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Dec 7, 2021

611_0002

B-06409945401028

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06409945401028
Reference / catalog number: 611_0002

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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

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	Nov 1, 2013	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06409945401028
Basic UDI-DI: B-06409945401028
Reference / catalog number: 611_0002
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

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.