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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

TK302 — Class I MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Jan 30, 2025

TK302

B-6430029912222V9

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: D-6430029912222V9
Reference / catalog number: TK302

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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.

CW999
Varoitukset: Älä käytä, jos olet allerginen tai herkkä ainesosille (sis. chiliuutetta). Fyysinen rasitus tai lämpö (esim. sauna) saattaa voimistaa lämpövaikutusta. Vältä aineen joutumista silmiin, limakalvoille ja haavoihin. Ei suositella käyttöä raskauden tai imetyksen aikana. Ei alle 5-vuotiaille lapsille. Käänny lääkärin puoleen, ellei olosi parane 7 päivän jälkeen tai se huononee. Ei lasten ulottuville eikä näkyville. Vain ulkoiseen käyttöön. Haittavaikutukset: Ilmoita valmistajalle tai viranomaiselle.

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-6430029912222V9
Basic UDI-DI: B-6430029912222V9
Reference / catalog number: TK302
Issuing entity: EUDAMED

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: TuplaTeho kylmä/kuumageeli on kaksivaikutteinen geeli lihasten ja nivelten kiputilojen lievittämiseen. Viilentää nopeasti ja lämmittää pitkävaikutteisesti.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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