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BETATEX SPA

Italy IT-MF-000009955 Last updated 21 Oct 2026

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Devices
14
Registries
EUDAMED
FDA recalls
0

Catalogue14

EUDAMED certificates2

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

EUDAMED certificates (2)

ISTITUTO SUPERIORE DI SANITA' 0373 2 certificates

  • CVD001723 Issued

    Technical documentation EU MDR

    Issued
    2 Nov 2023
    Expires
    23 Oct 2027
  • CVD001823 Issued

    Technical documentation EU MDR

    Issued
    2 Nov 2023
    Expires
    23 Oct 2027

Notified bodies

About

Per qualsiasi segnalazione di non conformità o problematiche riguardante i dispositivi medici BETATEX spa vi preghiamo di contattare l’indirizzo email [email protected]

From the manufacturer's own website, in their original language. Source

What BETATEX SPA makes

Betatex Spa manufactures a range of medical devices including connecting tubes such as the M-connect three-way stopcock/funnel, vascular tourniquets, and specialized telemetry systems with antibacterial properties. Their portfolio also covers peripheral vascular access products like PICC line dressing kits and lubricating gel syringes, as well as surgical and procedural sets for cardiology (aortocoronary bypass kits), ophthalmology (custom cataract packaging), and neuroradiology. Absorbent surgical drapes and sterile catheterization kits for bladder procedures are also part of their offerings.

The company’s devices fall under EU medical device classifications, including Class I, Class IIa, IIb, and III, and are registered in the EUDAMED database. Betatex Spa operates from Italy, adhering to EU regulatory requirements for medical devices.

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

Information

Country
Italy
Address
2, VIA RAFFAELLO , ASSISI, Italy
Phone
+390758004872
PRRC contact
Eleonora Tarpanelli
EUDAMED SRN
IT-MF-000009955