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SSCP SSCP-001003 — Establishment Labs

MD Atlas
Documents

Establishment Labs

SSCP SSCP-001003

Rev. 2

Summary of Safety and Clinical Performance

NB-validated

BSI Group The Netherlands B.V. (2797)

1 language

Covered devices

7445161Ergo2ZenBQClass III
7445161Ergo2ZenBQ
7445161Ergo2AXClass III
7445161Ergo2AX
7445161Ergo2DiamondDHClass III
7445161Ergo2DiamondDH
7445161Ergo2ZenTempNRClass III
7445161Ergo2ZenTempNR
7445161Ergo2OvalZenTempPQClass III
7445161Ergo2OvalZenTempPQ
7445161Ergo2DiamZenTempZSClass III
7445161Ergo2DiamZenTempZS
7445161Ergo2OvalWMClass III
7445161Ergo2OvalWM
7445161Ergo2OvalZenMPClass III
7445161Ergo2OvalZenMP

Linked certificate

No certificate is linked to this SSCP.

Overview

Reference number: SSCP-001003
Revision: 2
Version: 1
Issue date: Nov 11, 2024
Manufacturer
Manufacturer SRN: CR-MF-000008155
Notified body
Notified body SRN: 2797

Establishment Labs

BSI Group The Netherlands B.V.

Documents

LanguagesEN