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Organization name
UDI-DI code
Reference / catalog number

F12B02E015 — Class III MDR by DEVINTEC SAGL

MD Atlas
DEVINTEC SAGL

EUDAMED last updated this device on Oct 12, 2025

F12B02E015

7649993626FT42306VN

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DEVINTEC SAGL
UDI-DI code: 07649993626250
Reference / catalog number: F12B02E015

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Manufacturer information

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

Critical warnings

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

CW275
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649993626250
Basic UDI-DI: 7649993626FT42306VN
Reference / catalog number: F12B02E015
Issuing entity: GS1

Classification

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

Device details

Quantity: 15
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Size"00"

EMDN nomenclature code(s)

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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 Dermasectan7649993626FT42303VGOn the market Fybocalm Constipation relief7649993626FT42307VQOn the market Fybocalm Diarrhoea Relief7649993626FT42301VCOn 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