- Role
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MD Atlas update: Aug 29, 2026
CR-MF-000008155CR-MF-000008155Get the catalogue in Excel or CSV format — trade name, product reference, UDI and EMDN codes, legislation, quantity, last update, and more. The exact row count and price are confirmed before you pay.
2 EU importers place this manufacturer's devices
SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →Devices placed in 32 countries
Establishment Labs is a medical device manufacturer registered in EUDAMED. The company has 1,364 devices on the EU market across 32 countries. It holds 4 valid CE certificates. Headquartered in Alajuela, Costa Rica. Explore the regulatory profile, devices and certificates on MD Atlas.
Certificate MDR 768277Rev. R001Manufacturer
Establishment Labs
Notified body
BSI Group The Netherlands B.V.
2797Version
1
Valid from
6/12/2026
Valid until
1/5/2028
Certificate MDR 768275Rev. R001Manufacturer
Establishment Labs
Notified body
BSI Group The Netherlands B.V.
2797Version
1
Valid from
6/12/2026
Valid until
1/5/2028
Certificate MDR 798371Rev. R001Manufacturer
Establishment Labs
Notified body
BSI Group The Netherlands B.V.
2797Version
1
Valid from
6/12/2026
Valid until
1/1/2030
Certificate MDR 745219Rev. R001Manufacturer
Establishment Labs
Notified body
BSI Group The Netherlands B.V.
2797Version
1
Valid from
6/12/2026
Valid until
5/22/2027
Showing 1–25 of 36 device families.
7445161ErgoroundZen8Y7445161Ergo2ZenBQ7445161InflataballoonPA7445161Ergo2AX7445161injector7R7445161PortlocatorUY7445161VelvetPlusZenEJ7445161Ergo2DiamondDH7445161RoundsizersYE7445161SilkPlusS47445161ErgoroundR57445161SilkPlusZen8Z7445161ErgoVelvetZenPE7445161ErgoVelvetM57445161VelvetPlus62B-07445161017659B-07445161017666B-07445161017673B-07445161017680B-07445161017604B-07445161017611B-07445161017628B-07445161017635B-07445161017642B-07445161017543Showing 1–25 of 1364 devices.