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Organization name
UDI-DI code
Reference / catalog number

ARTHROFAR ICE GEL — Class I MDD by LABIALFARMA –…

MD Atlas
LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.

EUDAMED last updated this device on Jun 23, 2025

ARTHROFAR ICE GEL

B-03830073883364

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
UDI-DI code: 03830073883364
Reference / catalog number: MGC000

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View device family (Basic UDI)

Manufacturer information

Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
SRN: PT-MF-000003551
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
Keep out of the sight and reach of children.Please carefully read the accompanying instructions of use leaflet before using this product.External Use. Do not ingest.Do not inhale.This product should not be used in children under 6 years old. Do not use in case of pregnancy or breastfeeding.Do not apply on damaged skin. Do not use in case of muscle breakage. Do not apply on post-surgical wounds.Do not use in case of hypersensivity or allergy to one or ingredientes of the medical device.Avoid contact with eyes and mucous membranes. In case of sensibility to the product or accidental contact with eyes and mucous membranes, rinse immediately with plenty of water and seek medical advice.Recommended usage time is 7 days. If symptoms persist after this period, consult your doctor or pharmacist. Do not use for more than 7 days without consulting your doctor or pharmacist.In case of persistence or worsening of symptoms, consult your doctor or pharmacist. In case of appearance of undesirable adverse effects, you should stop using the product.Do not use 12 months after opening the tube.Do not take this product after the expiry date which is stated on the blister and carton box.Do not use the product if the box is open or damage.

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Market distribution

Primary placement in Portugal; available across 1 country total.

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

Device identification

Trade name: ARTHROFAR ICE GEL
UDI-DI code: 03830073883364
Basic UDI-DI: B-03830073883364
Reference / catalog number: MGC000
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: Menthol Gel - Cryotherapy is an external Gel containing as active ingredients alcohol, menthol and eucalyptol. It’s presented in a 100 mL tube. This medical device is indicated for the relief of muscular, joint and post-injury pains, in particular alleviating pain due to sprains, strains, tendonitis, knocks and bumps.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03830073883364

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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

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