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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

101230 — Class I MDR by Unigroup ApS

MD Atlas
Unigroup ApS

EUDAMED last updated this device on Jan 21, 2026

101230

57064481012TAGWY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unigroup ApS
UDI-DI code: 04016369551233
Reference / catalog number: 101230

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Manufacturer information

Organization name: Unigroup ApS
SRN: DK-MF-000009459
Manufacturer status: Active

Critical warnings

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

CW011
his product must be handled carefully and in accordance with the instructions for use. - Consult your doctor prior to use, if you have a history of skin cancer, have Hemophilia or if the skin tag shows signs of skin disease or infection. - Note that the withered skin tag will be necrotic after a few days. This is normal as the device will stop the flow of blood to the skin tag. - If you are in any doubt about whether the condition in question is in fact a skin tag, you should contact your doctor before initiating self-treatment. Do not use Fibrocontrol if you are allergic to one or more of its ingredients/ materials. - For external use only. - Keep out of reach and sight of children. - Fibrocontrol is safe to use during pregnancy and when breast feeding. - Do not use Fibrocontrol for removal of skin tags on the eyelids or near the eye, if the skin tag is not flesh coloured, does not fit within the diameter of the applicator (the skin tag must be max. 3mm in diameter at the base and max 5 mm in height) or is bleeding. - Note that the skin tag device might not stay in place in groin or skin folds. - Do not use under the age of 18 years. - Do not use if the device is damaged.

Market distribution

Primary placement in Slovenia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04016369551233
Basic UDI-DI: 57064481012TAGWY
Reference / catalog number: 101230
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
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

Related devices

10103557064481010KERATOLYTICJXOn the market 10103557064481010KERATOLYTICJXOn 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.