BETATEX SPA
Italy IT-MF-000009955 Last updated 21 Oct 2026
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- Devices
- 14
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Telo Cesareo 260X300X180 C/Film Iodato Ref MTT0523-I/BX-01
M-connect - CONNECTING TUBE MLL 3WAYS STOPCOCK/FUNNEL 15CM Ref WPV0006S (B-806835)
Lacci Vascolari Ref MTK06661
Telo Isolam. Vertic. CM250X330 Iodato Ref MTT0590-I
PICC Line Dressing Kit Ref PICC Line Dressing Kit
Picc Line Dressing Kit Ref MTK1058/ISK-19
Siringa Gel Lubrificante Ref MTK0026
Set By Pass Aortocoronarico Ref SF3064SE_T
Custom Pack Cataratta Ref SB0039SE
MTT1010/Bx-15_AV2 A Set Procedurale Chir Ref SE0164SEA
Kit Per Cateterismo Vescicale Ref MTK1076/FCR1
Set Neuroradiologia Ref SF3070SE_TR1
Tecnodrape Ref MTT04560-I
Telo 75X120 Cm In Super Assorbente Ref T76AF00000S
EUDAMED certificates
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
Related companies
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]
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.
Information
- Country
- Italy
- Address
- 2, VIA RAFFAELLO , ASSISI, Italy
- Website
- www.betatex.com
- [email protected]
- Phone
- +390758004872
- PRRC contact
- Eleonora Tarpanelli
- EUDAMED SRN
- IT-MF-000009955