Skip to content

Digitec S.r.l.

Italy IT-MF-000007792 Last updated 17 Sep 2026

Is this your brand? Sign in to claim this brand

Devices
21
Registries
EUDAMED
FDA recalls
0

Catalogue21

  • Teseo Ref DRX_01_024

    Class IIb EUDAMED Active

  • Inside C-Arm Ref ARM_01_006

    Class I EUDAMED Active

  • Odis Ref ARM_01_019

    Class IIb EUDAMED Active

  • Odis Ref ARM_01_001

    Class IIb EUDAMED Active

  • Teseo Ref DRX_01_001

    Class IIb EUDAMED Active

  • Odis Ref ARM_01_006

    Class IIb EUDAMED Active

  • Eracle Ref DRF_01_002

    Class IIb EUDAMED Active

  • Teseo Ref DRX_01_021

    Class IIb EUDAMED Active

  • Odis Ref ARM_01_017

    Class IIb EUDAMED Active

  • Teseo Ref DRX_01_023

    Class IIb EUDAMED Active

  • Inside_sw Ref DRF_03_005

    Class IIb EUDAMED Active

  • DRF4343-Dt Ref DRF_01_010

    Class IIb EUDAMED Active

  • 3D-Cam Pilot Ref 3DCam C

    Class I EUDAMED Active

  • Teseo Ref DRX_01_007

    Class IIb EUDAMED Active

  • Teia Ref DTS C

    Class IIa EUDAMED Active

  • Inside_sw Ref DRF_03_006

    Class IIb EUDAMED Active

  • Teseo Ref DRX_01_025

    Class IIb EUDAMED Active

  • Odis Ref ARM_01_018

    Class IIb EUDAMED Active

  • O-D4000WS Ref DRX_01_006

    Class IIb EUDAMED Active

  • VDX Next Ref DRX_01_010

    Class IIb EUDAMED Active

  • Eracle Ref DRF_01_001

    Class IIb EUDAMED Active

EUDAMED certificates1

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

EUDAMED certificates (1)

TUV Rheinland Italia SRL 1936 1 certificate

  • ITH 1450755 1 Supplemented

    Quality management system EU MDR

    Issued
    26 Feb 2025
    Expires
    28 Dec 2027
    Reason
    Other

Related companies

Notified bodies

About

Digitec Srl | Via Caduti Lecchesi a Fossoli, 17 23900 Lecco (LC) - ITALYCapitale sociale 75.000 interamente versato CCIAA Lecco n. REA 198209 | Cod. Fiscale 00527870141 | P.IVA 01647550134

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

What Digitec S.r.l. makes

Digitec S.r.l. manufactures imaging and diagnostic devices, including C-arm systems (e.g., INSIDE C-ARM), 3D imaging cameras (e.g., 3D-Cam Pilot), and software solutions for medical imaging (e.g., INSIDE_SW, TESEO). Their portfolio also includes fluoroscopic systems (e.g., ODIS, ERACLE, TEIA) and digital radiography units (e.g., O-D4000WS, DRF4343-DT).

The company’s devices are classified under EU Medical Device Regulations as Class I, Class IIa, and Class IIb, with all products listed in the EU’s eudamed registry. Digitec S.r.l. is based in Lecco, Italy.

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

Information

Country
Italy
Address
17, Via Caduti Lecchesi a Fossoli, Lecco, Italy
Phone
+39 0341 364617
PRRC contact
Laura Monti
EUDAMED SRN
IT-MF-000007792