EUDAMED device

PRIMA ENT -Motorized Fine Focus

EUDAMED device 00810178550241 · Labo America Inc.

Key facts

Primary DI 00810178550241
Trade name PRIMA ENT -Motorized Fine Focus
Device name Surgical (Operating) Microscopes
Reference or catalog number 6137000-100
Model Prima,Prima Mu,Prima Swift,Stella,Stella N,Prima Lite
Manufacturer Labo America Inc.
Manufacturer SRN US-MF-000044352
Risk class Class I
EMDN code Z12011101
EMDN description OPERATIVE MICROSCOPES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date May 28, 2025

At a glance

  • No Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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