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Organization name
UDI-DI code
Reference / catalog number

BIOFROST RELIEF 75ML — Class I MDD by Viking Lab Oy

MD Atlas
Viking Lab Oy

EUDAMED last updated this device on Jul 21, 2023

BIOFROST RELIEF 75ML

B-06430070090047

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Viking Lab Oy
UDI-DI code: 06430070090047
Reference / catalog number: BF1003

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Manufacturer information

Organization name: Viking Lab Oy
SRN: FI-MF-000005746
Manufacturer status: Active

Critical warnings

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

CW011
For external use only. Do not use on wounds or damaged skin. Do not apply to irritated skin or if excessive irritation develops. Avoid contact with the eyes and mucous membranes. Do not use with other creams, gels, or devices. Do not bandage. Store in a cool and dry place with lid closed tightly. Keep away from excessive heat. Any serious incident that has occurred in relation to the product should be reported to the manufacturer. KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS OLD

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: BIOFROST RELIEF 75ML
UDI-DI code: 06430070090047
Basic UDI-DI: B-06430070090047
Reference / catalog number: BF1003
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: BIOFROST® RELIEF (COLD GEL) Pain relief gel is a fast and effective cold treatment for repetitive strain injury and sports related pain. Cold reduces swelling, releases muscle tension, and speeds up recovery in injuries and muscle exertion. INDICATIONS: For the temporary relief of minor aches and pains of muscles and joints. DIRECTION FOR USE: Apply a thin layer to affected area, make a second application in 10 minutes. Repeat as necessary, but not more than 4 times daily. Consult a doctor before use if you are pregnant or nursing or have sensitive skin. Wash hands after use. WARNINGS: For external use only. Do not use on wounds or damaged skin. Do not apply to irritated skin or if excessive irritation develops. Avoid contact with the eyes and mucous membranes. Do not use with other creams, gels, or devices. Do not bandage. Store in a cool and dry place with lid closed tightly. Keep away from excessive heat. Any serious incident that has occurred in relation to the product should be reported to the manufacturer. KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS OLD.
Additional information URL: https://eifu.biofrost.fi/
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

Related devices

BIOFROST ACTIVE 100MLB-06430070090443On the market BIOFROST ACTIVE 3MLB-06430070090139On the market BIOFROST ACTIVE 500MLB-06430070090528On the market BIOFROST ACTIVE 75MLB-06430070090467On the market BIOFROST RELIEF 100MLB-06430070090412On the market

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.