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DirectoryBusiness & Technical ServicesTechnical Consulting & EngineeringBaarObelis Swiss GmbH
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Obelis Swiss GmbH

Summary

About the company

The core activity of Obelis is to provide services as a Swiss Authorised Representative for companies wishing to market medical devices and in-vitro diagnostics (IVDs) in Switzerland. This includes, among other things: Product registration with the Swiss authority Swissmedic, Review and creation of technical documentation, Consulting and support for compliance with regulatory requirements, and Swiss Marking (certification of products for the Swiss market). The company also supports compliance with EU and UK regulations and offers consulting and support for certification according to ISO 9001:2015 and ISO 13485:2016.

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Industry:Technical Consulting & Engineering
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Swiss Authorised Representative
Swiss authorised representative for non-Swiss manufacturers of medical devices and in-vitro diagnostic devices; assumes CH-REP role, supports Swissdamed registration, handles documentation and Swissmedic communication.
Product Registration
Product registration with Swissmedic for medical devices, including device notification and registration support for Swiss market access and Swissdamed-related requirements.
Technical documentation
Technical documentation review and support for medical devices, including compliance checks, availability of documentation for inspection, and related post-market surveillance elements.
Swiss consultancy, legal & training
Swiss regulatory consultancy, legal guidance and training for market entry, technical documentation review, Swiss labelling review, ongoing updates and market strategy support.
Swiss marking
Support for obtaining Swiss MD marking or CE marking for medical devices, including conformity marking requirements and assistance with the Swiss market process.

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Location

Ruessenstrasse 12
6340 Baar
Opening hours
Mon
09:00 - 18:00
Tue
09:00 - 18:00
Wed
09:00 - 18:00
Thu
09:00 - 18:00
Fri
09:00 - 16:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Limited Liability Company
UID
CHE-407.391.181
Founded
2021 · 5 years
Last commercial register change
September 6, 2021
Employees
1 to 10

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