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DEVINTEC SAGL

Switzerland CH-MF-000020271 Last updated 21 Oct 2026

Devices
33
Registries
EUDAMED
FDA recalls
0

Catalogue33

EUDAMED certificates3

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (3)

BUREAU VERITAS ITALIA S.P.A. 1370 3 certificates

  • IT325651 Supplemented

    Quality management system EU MDR

    Issued
    26 Sep 2025
    Expires
    7 Sep 2028
    Reason
    Other
  • IT326645 Supplemented

    Technical documentation EU MDR

    Issued
    18 Mar 2025
    Expires
    7 Sep 2028
    Reason
    Add device or group
  • IT336677 Issued

    Quality management system EU MDR

    Issued
    22 Oct 2024
    Expires
    7 Sep 2028

Authorised representatives

Notified bodies

About

Devintec is a privately owned pharmaceutical company based in Switzerland pioneer in research and developing innovative substance-based medical devices.

From the manufacturer's own website. Source

What DEVINTEC SAGL makes

Devintec SAGL manufactures gastrointestinal and dermatological medical devices, including antacids and anti-gas formulations like Fybocalm for wind and constipation relief, Gelsectan for pain relief, and Gaviscon for intestinal bloating. Their portfolio also includes treatments for diarrhea (Gavidigest) and topical dermatological products such as Dermasectan. Additionally, they produce Vissect, a substance-based medical device for unspecified gastrointestinal applications.

The company’s devices are classified under EU medical device regulations as Class IIa and Class III, with all products listed in the EUDAMED database. Devintec SAGL is based in Switzerland and adheres to European regulatory requirements for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Devintec SAGL manufacture?

Devintec SAGL specializes in gastrointestinal and dermatological medical devices. Their portfolio includes antacids and anti-gas formulations like Fybocalm (for wind and constipation relief), Gelsectan (for pain relief), and Gaviscon (for intestinal bloating). They also produce treatments for diarrhea (Gavidigest) and topical dermatological products such as Dermasectan. Additionally, they develop Vissect, a substance-based device for gastrointestinal applications.

Where is Devintec SAGL based, and what regulatory framework does it follow?

Devintec SAGL is based in Switzerland and operates under European medical device regulations. Since their devices are listed in the EUDAMED database, they comply with the EU Medical Device Regulations (MDR), which classify their products as either Class IIa or Class III based on risk levels.

Which regulatory registries list Devintec SAGL’s medical devices?

Devintec SAGL’s medical devices are listed in the EUDAMED database, which is the European Union’s central registry for medical device information. This registry ensures transparency and traceability of devices authorized under EU medical device regulations.

How are Devintec SAGL’s devices classified under EU regulations?

Devintec SAGL’s devices are classified as either Class IIa or Class III under the EU Medical Device Regulations. The classification depends on the risk associated with the device’s intended use—Class III includes higher-risk devices requiring stricter scrutiny, while Class IIa covers moderate-risk products.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Switzerland(from SRN)
Address
14, Corso Elvezia, Lugano, Switzerland
Phone
0041916014051
PRRC contact
Simone Brancè
EUDAMED SRN
CH-MF-000020271