Manufacturer

Optimedical

United StatesLegal entities : OPTI Medical Systems, Inc.

Markets : Germany · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 3 · class II · latest in 2021 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

2 categories, 19 models including 19 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
IVD general use consumables devices - other accessories	W0580	OPTI CALIBRATION GAS OPTI CCA, OPTI CCA -TS CALIBRATION GAS98/79 OPTI CCA SRC LEVEL 1 OPTI CCA, OPTI CCA-TS SRC LEVEL 198/79 OPTI CCA -TS2 ANALYZER CALIBRATION GAS98/79 OPTI CCA B-60 CASSETTE98/79 OPTI CCA B-LAC CASSETTE98/79 12 others OPTI CCA CASSETTES B98/79 OPTI CCA E-CA CASSETTE98/79 OPTI CCA E-CL CASSETTE98/79 OPTI CCA E-GLU CASSETTE98/79 OPTI CCA E-LYTE CASSETTE98/79 OPTI CCA OPTI CHECK98/79 OPTI CCA OPTI CHECK PLUS98/79 OPTI CCA SRC LEVEL 2 OPTI CCA, OPTI CCA TS SRC LEVEL 298/79 OPTI CCA SRC LEVEL 3 OPTI CCA, OPTI CCA TS SRC LEVEL 398/79 OPTI CCA-TS2 Hb Cal Cassette98/79 OPTI CCA-TS2 MULTI-LEVEL SRC98/79 OPTI Hb Cal Cassette OPTIC CCA, OPTI CCA TS Hb Cal Cassette98/79	– 98/79	EUDAMED record Report an error
Blood gas analysers - with classic profile (pH, PO2, PCO2, hct + electrolytes)	W0201040101	OPTI CCA -TS Blood Gas Analyzer OPTI CRITICAL CARE ANALYZER - TS (TOUCHSCREEN) OPTI CCA -TS2 Blood Gas Analyzer OPTI CRITICAL CARE ANALYZER - TS2	A IVDR	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.

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