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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

Akutol™ Plaster Remover Spray — Class I MDR by AVEFLOR, a.s.

MD Atlas
AVEFLOR, a.s.

EUDAMED last updated this device on Mar 12, 2026

Akutol™ Plaster Remover Spray

859401370Z30NB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AVEFLOR, a.s.
UDI-DI code: 08594013705066
Reference / catalog number: Z300007

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Manufacturer information

Organization name: AVEFLOR, a.s.
SRN: CZ-MF-000003103
Manufacturer status: Active

Critical warnings

11 warnings recorded — scroll inside the panel to see all entries.

CW038
EUDAMED did not publish a description for this code.
CW999
Any serious adverse event related to this product should be reported to the manufacturer and the State Institute for Drug Control.
CW999
Protect your eyes from the spray.
CW139
EUDAMED did not publish a description for this code.
CW140
EUDAMED did not publish a description for this code.
CW158
EUDAMED did not publish a description for this code.
CW054
EUDAMED did not publish a description for this code.
CW268
EUDAMED did not publish a description for this code.
CW157
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Oct 5, 2021	Still on market
Slovenia	Oct 5, 2021	Still on market

Device identification

Trade name: Akutol™ Plaster Remover Spray
UDI-DI code: 08594013705066
Basic UDI-DI: 859401370Z30NB
Reference / catalog number: Z300007
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: AKUTOL™ Patch Remover is a solution of volatile, non-greasy silicones in the form of a propellant spray. It is used for easy removal of sticking plasters, transdermal patches, adhesive bandages and other medical aids attached to the body surface (nicotine patches, ECG electrodes, cannulae, tapes, etc.). Safe and gentle on skin. Evaporates completely. Does not affect the healing process and it can not be absorbed into the wound. Can be used on sensitive, very dry, cracked or damaged skin. It leaves the treated area clean and ready for applying a new dressing.
Additional information URL: https://www.akutol.cz/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9003SOLUTIONS FOR ADHESIVE TAPE REMOVAL

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

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