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Sign in to claim this brandEra 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
- Website
- www.endotics.com
- —
- —
- [email protected]
- Phone
- +390587635235
- PRRC Contact
- Samuele Gorini
- EUDAMED SRN
- IT-MF-000034111
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CleanSwitch | ENDO-CSW | EUDAMED | Class IIa | Active |
| KIT monouso RoboClean | ENDO-RBC-SU | EUDAMED | Class IIa | Active |
| Sonda Monouso Endotics | EWSND-TC | EUDAMED | Class IIa | Active |
| Waterjet | ENDO-WTJ | EUDAMED | Class IIa | Active |
| RoboClean | ENDO-RBC | EUDAMED | Class IIa | Active |
| KIT monouso CleanSwitch | ENDO-CSW-SU | EUDAMED | Class IIa | Active |
| KIT monouso Waterjet | ENDO-WJT-SU | EUDAMED | Class IIa | Active |
| Workstation Endotics Serie 4 | ENDWS4-TC | EUDAMED | Class IIa | Active |
| Workstation Endotics Ver TC | ENDWKS-TC | EUDAMED | Class IIa | Active |
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