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Era Endoscopy Srl

Italy·IT-MF-000034111

Last updated September 18, 2026

About

Endotics is an innovative robotic colonoscopy platform with a disposable probe, gentle locomotion, and a workflow designed for safer, more comfortable, and efficient exams.

From the manufacturer's own website. Source

What Era Endoscopy Srl makes

Era Endoscopy Srl manufactures reusable robotic workstations for colonoscopy procedures, including the Endotics Series 4 and Endotics Ver TC models, alongside single-use accessories such as the CleanSwitch, RoboClean, and Waterjet systems. Their portfolio also includes disposable sondas (probes) for endoscopy, as well as reusable and disposable cleaning kits designed for use with these robotic platforms.

The company’s devices are classified as Class IIa under EU regulations and are listed in the EUDAMED database. Era Endoscopy Srl is based in Italy and adheres to EU medical device compliance requirements for these products.

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 Era Endoscopy Srl manufacture?

Era Endoscopy Srl produces reusable robotic workstations for colonoscopy, including the Endotics Series 4 and Endotics Ver TC models. Their portfolio also includes single-use accessories like the CleanSwitch, RoboClean, and Waterjet systems, as well as disposable sondas (probes) and reusable/disposable cleaning kits designed for use with these robotic platforms. These devices are primarily intended to enhance safety, comfort, and efficiency during endoscopic procedures.

Where is Era Endoscopy Srl based, and what regulatory region does it serve?

Era Endoscopy Srl is based in Italy and develops medical devices compliant with EU regulations. Their products are designed to meet the requirements of the European market, including classification under EU medical device directives and registration in the EUDAMED database.

Which regulatory registries list Era Endoscopy Srl’s devices?

Era Endoscopy Srl’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry tracks device information, including manufacturer details, classifications, and regulatory status, ensuring transparency for healthcare professionals and regulators.

How are Era Endoscopy Srl’s devices classified under EU regulations?

All of Era Endoscopy Srl’s devices fall under Class IIa classification according to EU medical device regulations. This classification applies to devices that pose a moderate risk and require conformity assessment procedures, including technical documentation review and compliance with essential safety and performance requirements.

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

Information

Country
Italy
Address
26, Via Cava, Cascina, Italy
LinkedIn
—
Facebook
—
Phone
+390587635235
PRRC Contact
Samuele Gorini
EUDAMED SRN
IT-MF-000034111
FDA FEI Number
—
DUNS Number
—

Catalogue (9)

DeviceModel / ReferenceRegistriesClassStatus
CleanSwitch ENDO-CSW
EUDAMED
Class IIaActive
KIT monouso RoboClean ENDO-RBC-SU
EUDAMED
Class IIaActive
Sonda Monouso Endotics EWSND-TC
EUDAMED
Class IIaActive
Waterjet ENDO-WTJ
EUDAMED
Class IIaActive
RoboClean ENDO-RBC
EUDAMED
Class IIaActive
KIT monouso CleanSwitch ENDO-CSW-SU
EUDAMED
Class IIaActive
KIT monouso Waterjet ENDO-WJT-SU
EUDAMED
Class IIaActive
Workstation Endotics Serie 4 ENDWS4-TC
EUDAMED
Class IIaActive
Workstation Endotics Ver TC ENDWKS-TC
EUDAMED
Class IIaActive

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