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Organization name
UDI-DI code
Reference / catalog number

C12B02E030HU — Class III MDR by DEVINTEC SAGL

MD Atlas
DEVINTEC SAGL

EUDAMED last updated this device on Feb 3, 2025

C12B02E030HU

7649993626FT42306VN

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DEVINTEC SAGL
UDI-DI code: 07649993626076
Reference / catalog number: C12B02E030HU

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Manufacturer information

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

Related devices

Dermasectan7649993626FT42303VGOn the market Dermasectan7649993626FT42303VGOn the market Dermasectan7649993626FT42303VGOn the market Fybocalm Constipation relief7649993626FT42307VQOn the market Fybocalm Diarrhoea Relief7649993626FT42301VCOn the market

Critical warnings

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

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

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Hungary		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649993626076
Basic UDI-DI: 7649993626FT42306VN
Reference / catalog number: C12B02E030HU
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: 30
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: SIZE 3

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

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