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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

TK403 — Class IIa MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Nov 24, 2025

TK403

B-6430029912451VS

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: D-6430029912451VS
Reference / catalog number: TK403

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Manufacturer information

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

Critical warnings

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

CW999
Käänny lääkärin puoleen, jos oireet pahenevat. Ei lasten ulottuville eikä näkyville. Vain ulkoiseen käyttöön. Ei silmiin eikä sisäiseen käyttöön.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Jan 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-6430029912451VS
Basic UDI-DI: B-6430029912451VS
Reference / catalog number: TK403
Issuing entity: EUDAMED

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: Desipower Antiseptisk spray - för rengöring och desinfektion av ytliga sår, skrubbsår, och andra hudskador. Svider inte. Lindrar svidnad och hudirritation förorsakad av t.ex. Myggbett.
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

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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.