Manufacturer

Gyrus ACMI

United StatesLegal entities : Gyrus ACMI, Inc.

Markets : Germany · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 44 · PMA : 2 · class I, II, III · latest in 2026 · see on the FDA website

EU representative : Olympus Europa SE & Co. KG (Germany)

7 categories, 74 models including 74 on the market, 1 country

Export to CSV

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
Lens cleaning units	Z12029015	Footpedal, Lens Cleaner LCS1500UNOL93/42 LCS1530BTOL93/42 LCS1530TPOL93/42 LCS1545BTOL93/42 18 others LCS1545TPOL93/42 LCS1570BTOL93/42 LCS1570TPOL93/42 LCS1800UNST93/42 LCS1830BTST93/42 LCS1830TPST93/42 LCS1845BTST93/42 LCS1845TPST93/42 LCS1870BTST93/42 LCS1870TPST93/42 LCS4K00UNOL93/42 LCS4K30BTOL93/42 LCS4K30TPOL93/42 LCS4K45BTOL93/42 LCS4K45TPOL93/42 LCS4K70BTOL93/42 LCS4K70TPOL93/42 LCTS100S93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Therapeutic lasers	Z120615	LCCONS10093/42 MDCONS10093/42 Soltive Surgical laser system accessories - footswitches Soltive Surgical laser system accessories - power cord2 refs TFL-AFSWL93/42 14 others TFL-CPLU93/42 TFL-CSLU93/42 TFL-FBX150BS93/42 TFL-FBX150R93/42 TFL-FBX150S93/42 TFL-FBX200BS93/42 TFL-FBX200R93/42 TFL-FBX200S93/42 TFL-FBX365R93/42 TFL-FBX365S93/42 TFL-FBX550R93/42 TFL-FBX550S93/42 TFL-FBX940R93/42 TFL-FBX940S93/42	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Ultrasonic endoscopic lithotripters	Z12020302	SHOCKPULSE LITHOTRIPSY TRANSDUCER93/42 SPL-G93/42 SPL-PDBX09793/42 SPL-PDBX15093/42 SPL-PDBX18393/42 8 others SPL-PDBX34093/42 SPL-PDBX37693/42 SPL-PR09793/42 SPL-PR15093/42 SPL-PR18393/42 SPL-PR34093/42 SPL-PR37693/42 SPL-SR93/42	IIa, IIb 93/42	EUDAMED record Report an error
Various ENT instruments - hardware accessories	Z12149080	ENT Microdebrider accessories ICLIP20093/42 MDALA93/42 MDASA93/42 MDHP100A93/42 6 others MDHP100S93/42 MDHP20093/42 MDSLA93/42 MDSSA93/42 MDSTAP93/42 NCGRIP93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Various ENT instruments - consumables	Z12149085	BEMTS101DC93/42 TS100S93/42 TS101DC93/42 TS102SF93/42 TS200S93/42	IIa 93/42	EUDAMED record Report an error
Instruments for ultrasonic surgery - hardware accessories	Z12010880	ShockPulse Accessories - power cord, footswitch2 refs ShockPulse lithotripsy accessories (nosecone, wrench, stylet)3 refs	I MDR	EUDAMED record Report an error
Electrosurgical units (ESU) for general use	Z12010902	GYRUS, PK-SP FOOTSWITCH	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.