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Organization name
UDI-DI code
Reference / catalog number

Z350000 — Class IIa MDR by AVEFLOR, a.s.

MD Atlas
AVEFLOR, a.s.

EUDAMED last updated this device on Oct 20, 2025

Z350000

859401370Z35NM

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AVEFLOR, a.s.
UDI-DI code: 08594013703581
Reference / catalog number: Z350000

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Manufacturer information

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

Related devices

Trioderm® CARE Warts Removal Cryospray859401370Z28NQOn the market Z350005859401370Z35NMOn the market Z36859401370Z30NBOn the market Z300000859401370Z30NBOn the market Akutol™ Plaster Remover Spray859401370Z30NBOn the market

Critical warnings

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

CW268
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW157
EUDAMED did not publish a description for this code.
CW999
Packaging may explode if overheated. AKUTOL™ Burn Spray is not intended for deep partial-thickness burns (Deep combustio bullosa) or full thickness burns (Combustio escharotica), when the epidermis and dermis is deeply damaged or full dermis is lost. Do not use AKUTOL™ Burn Spray in case of an allergic reaction to any of the contained ingredient. Do not use for children under 3 years of age. Consult a physician about the use in case of pregnancy or breastfeeding. Do not use on face. Avoid contact with eyes and mucous membranes.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Sep 26, 2025	Sep 25, 2030

Device identification

Trade name: not provided
UDI-DI code: 08594013703581
Basic UDI-DI: 859401370Z35NM
Reference / catalog number: Z350000
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: AKUTOL™ Burn Spray is a hydrogel in form of spray containing hyaluronic acid and plant excipients. AKUTOL™ Burn Spray is used for the treatment of minor home surface burns of 1st and 2nd degree and skin after excessive sunbathing. 50 ml of product in aerosol can.
Additional information URL: https://www.akutol.cz/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - 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