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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

151_100 — Class I MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Dec 30, 2021

151_100

B-06418029906250

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06418029906250
Reference / catalog number: 151_100

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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
Avoid contact with eyes, mucous membranes and wounds. Do not use during pregnancy or nursing. Not for children under the age of 2. Keep out of the sight and reach of children. Consult your physician if you do not feel better or if you feel worse after 7 days. For external use only.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Jan 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06418029906250
Basic UDI-DI: B-06418029906250
Reference / catalog number: 151_100
Issuing entity: GS1

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: Ice Power Strong cold gel effectively relieves pain in the muscles. Use, for example, for prolonged pain sensations and muscle tensions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 150 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
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Software identification