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Organization name
UDI-DI code
Reference / catalog number

150_1551 — Class I MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Dec 30, 2021

150_1551

B-06418029905352

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06418029905352
Reference / catalog number: 150_1551

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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. For external use only. Keep out of reach of children.

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement	Jan 23, 2019	Jul 21, 2024
Slovenia	Jan 23, 2019	Jul 21, 2024

Device identification

Trade name: not provided
UDI-DI code: 06418029905352
Basic UDI-DI: B-06418029905352
Reference / catalog number: 150_1551
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 Sport Gel relieves pain in muscles and joints. It reduces swelling caused by injuries and relieves inflammation. In addition, the ingredients increase blood circulation, release muscle tension and promote muscle recovery after physical exertion.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 150 MU04

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