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Organization name
UDI-DI code
Reference / catalog number

Dermasectan — Class IIa MDR by DEVINTEC SAGL

MD Atlas
DEVINTEC SAGL

EUDAMED last updated this device on Nov 13, 2025

Dermasectan

7649993626FT42303VG

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DEVINTEC SAGL
UDI-DI code: 07649993626151
Reference / catalog number: C41E07L003

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Manufacturer information

Organization name: DEVINTEC SAGL
SRN: CH-MF-000020271
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: Dermasectan
UDI-DI code: 07649993626151
Basic UDI-DI: 7649993626FT42303VG
Reference / catalog number: C41E07L003
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: 3
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 3 ml

EMDN nomenclature code(s)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

Dermasectan7649993626FT42303VGOn the market Dermasectan7649993626FT42303VGOn the market Fybocalm Constipation relief7649993626FT42307VQOn the market Fybocalm Diarrhoea Relief7649993626FT42301VCOn the market Fybocalm Wind & Bloating relief7649993626FT42306VNOn the market

Certificates

Certificate health across this manufacturer's portfolio.

IT325651Supplemented
Quality management systemNotified body: 1370Expiry: Sep 7, 2028
IT326645Supplemented
Technical documentationNotified body: 1370Expiry: Sep 7, 2028
IT336677Issued
Quality management systemNotified body: 1370Expiry: Sep 7, 2028