Manufacturer

OMNIlife science

United StatesLegal entities : OMNIlife science, Inc.

Markets : France · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 28 · class II · latest in 2021 · see on the FDA website

EU representative : CORIN FRANCE SAS (France)

3 categories, 28 models including 28 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Stereotactic orthopaedic surgery instruments - hardware accessories	Z12130480	iBlock Motor Unit OmniBotics93/42 OMNIBot Cable OmniBotics93/42 OMNIBot Enclosure Body OmniBotics93/42 OMNIBot Enclosure Cover OmniBotics93/42 OMNIBotics EU Station Laptop, ART 2.593/42 18 others OMNIBotics Station Camera93/42 OMNIBotics Station Camera- Branded93/42 OMNIBotics Station Cart, NON-UPS, Wired – Branded2 refs93/42 OMNIBotics Station Cart, with COMM Module93/42 OMNIBotics Station Case – Laptop, Camera, Motor Unit93/42 OMNIBotics Station Crate – Full System93/42 OMNIBotics Station Laptop, ART93/42 OMNIBotics Station Laptop, ART 2.7, NON-US93/42 OMNIBotics Station Laptop, ART 2.7, US93/42 OMNIBotics Station Laptop, ART and HIP93/42 OMNIBotics Station Power Cord, AUS93/42 OMNIBotics Station Power Cord, EU93/42 OMNIBotics Station Power Cord, Israel93/42 OMNIBotics Station Power Cord, South Africa93/42 OMNIBotics Station Power Cord, Switzerland93/42 OMNIBotics Station Power Cord, UK93/42 OMNIBotics Station Power Cord, US93/42 OMNIBotics US Station Laptop, ART 2.4 and HIP 1.093/42	IIa 93/42	EUDAMED record Report an error
Stereotactic orthopaedic surgery instruments - consumables	Z12130485	OMNIBotics BalanceBot Disposables Kit (no screws)93/42 OMNIBotics BalanceBot Disposables Kit (with screws)93/42 OMNIBotics Tracker Kit (Sterile Markers (NS-26311) and USB Drive NS-26029)93/42	I 93/42	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - other	Z12130599	BalanceBot Cable OmniBotics93/42 BalanceBot Motor Unit OmniBotics93/42	IIa 93/42	EUDAMED record Report an error

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