Manufacturer

Datex-Ohmeda

United StatesLegal entities : Datex-Ohmeda Inc.

Markets : Bulgaria · Croatia · Czechia · Denmark · Estonia · Finland · France · Germany · Greece · Hungary · Italy · Latvia · Lithuania · Netherlands · Norway · Poland · Portugal · Romania · Spain · Sweden and 2 more countries

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 103 · class II · latest in 2026 · see on the FDA website

EU representative : GE Healthcare Finland Oy (Finland)

eudamed@gehealthcare.com

12 categories, 87 models including 86 on the market, 1 country

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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
Anaesthesia systems - hardware accessories	Z1203010180	ABS ABSORBENT CANISTER REUSABLE93/42 Aladin2 DES Fixed Fill93/42 Aladin2 Desflurane Saf-fil2 refs93/42 Aladin2 Isoflurane Easy Fil93/42 Aladin2 Sevoflurane Closed FILL93/42 56 others Aladin2 Sevoflurane Easy-Fil3 refs93/42 Aladin2 Sevoflurane Quick Fil2 refs93/42 Aladin2 Sevoflurane SAFE-T-SEAL93/42 CBS Reusable Absorber Canister Serenity S Vaporizer BAXTER DES Safe-Fil BG, HR, CS, SK, SR CEE 7/7 Power Cord3 refs TEC 6 PLUS VAP DES 220/240V CS93/42 TEC 6 PLUS VAP DES 220/240V CS SERVICED93/42 TEC 6 PLUS VAP DES 220/240V DA93/42 TEC 6 PLUS VAP DES 220/240V DA SERVICED93/42 TEC 6 PLUS VAP DES 220/240V EL93/42 TEC 6 PLUS VAP DES 220/240V EL SERVICED93/42 TEC 6 PLUS VAP DES 220/240V EN93/42 TEC 6 PLUS VAP DES 220/240V EN EUROPE93/42 TEC 6 PLUS VAP DES 220/240V EN EUROPE SERVICED93/42 TEC 6 PLUS VAP DES 220/240V EN SERVICED93/42 TEC 6 PLUS VAP DES 220/240V ES93/42 TEC 6 PLUS VAP DES 220/240V ES SERVICED93/42 TEC 6 PLUS VAP DES 220/240V FI93/42 TEC 6 PLUS VAP DES 220/240V FI SERVICED93/42 TEC 6 PLUS VAP DES 220/240V FR93/42 TEC 6 PLUS VAP DES 220/240V FR SERVICED93/42 TEC 6 PLUS VAP DES 220/240V IT SERVICED93/42 TEC 6 PLUS VAP DES 220/240V NL93/42 TEC 6 PLUS VAP DES 220/240V NL SERVICED93/42 TEC 6 PLUS VAP DES 220/240V NO93/42 TEC 6 PLUS VAP DES 220/240V NO SERVICED93/42 TEC 6 PLUS VAP DES 220/240V SV93/42 TEC 6 PLUS VAP DES 220/240V SV SERVICED93/42 TEC 6 PLUS VAP DES 220/240V TR93/42 TEC 6 PLUS VAP DES 220/240V TR SERVICED93/42 TEC 6 PLUS VAP DES 220V ET93/42 TEC 6 PLUS VAP DES 220V ET SERVICED93/42 TEC 6 PLUS VAP DES 220V LT93/42 TEC 6 PLUS VAP DES 220V LT SERVICED93/42 TEC 6 PLUS VAP DES 220V LV93/42 TEC 6 PLUS VAP DES 220V LV SERVICED93/42 TEC 6 PLUS VAP DES 220V PL93/42 TEC 6 PLUS VAP DES 220V PL SERVICED93/42 TEC 6 PLUS VAP DES FIXED FILLER 220/240V TR93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V DA93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V DE93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V ES93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V FI93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V FR93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V HU93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V IT93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V NL93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V NO93/42 TEC 6 PLUS VAP DES FIXED FILLER 220V PL93/42 TEC 6 PLUS VAP DES FIXED FILLER 240V EL93/42 TEC 6 PLUS VAP DES FIXED FILLER 240V EN93/42 TEC 6 PLUS VAP DES FIXED FILLER 240V EN EUROPE93/42 TEC 6 PLUS VAP DES FIXED FILLER 240V SV93/42 TEC 6 PLUS VAP DES PT93/42 TEC 6 PLUS VAP DES PT SERVICED93/42 TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV3 refs	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Anaesthesia devices	Z1203010101	Aisys CS293/42 Carestation 620 A1, Carestation 650 A1, Carestation 650c A13 refs Carestation 750 A1 Carestation 750 & Carestation 750c2 refs Carestation 850, Carestation 850c2 refs CS600 V1 to V2 Upgrade BG Carestation 620 A1, Carestation 650 A1, Carestation 650c A13 refs 4 others TEC 6 PLUS VAP DES 220/240V DE93/42 TEC 6 PLUS VAP DES 220/240V DE SERVICED93/42 TEC 6 PLUS VAP DES 220/240V IT93/42 Avance CS293/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Neonatal radiant warmers	Z12080407	Giraffe Warmer M1118179 Lullaby Warmer - WARMER MAIN ASM, 115V for sea shipment3 refs Panda Freestanding Warmer 2063568-001 Panda iRes Warmer M1112198 Panda Wall Mount Warmer 2063570-001	IIb MDR	EUDAMED record Report an error
Neonatology instruments - other	Z12080499	Giraffe Shuttle 2094632-001 Giraffe Stand-alone Infant Resuscitation System Bag and Mask2 refs Lullaby Resus Plus – DISS2 refs	IIb MDR	EUDAMED record Report an error
Paediatric phototherapy equipment	Z12080401	Giraffe Blue Spot PT Lite3 refs Lullaby LED Phototherapy System 2052663-001	IIa MDR	EUDAMED record Report an error
Cardiotocographic telemetry instruments - consumables	Z1208010485	NOVII PATCH (BOX OF 10)3 refs	I MDR	EUDAMED record Report an error
Cardiotocographic telemetry instruments - hardware accessories	Z1208010480	NOVII INTERFACE CABLE - GE FECG3 refs	I MDR	EUDAMED record Report an error
Infusion instruments - hardware accessories	Z12030380	IV POLE 12 IN3 refs	I MDR	EUDAMED record Report an error
Mobile neonatal incubators	Z1208040302	Giraffe Incubator Carestation CS1 2082844-002	IIb MDR	EUDAMED record Report an error
Neonatal scales	Z12080402	Giraffe EU In-Bed Scale GS EU13 refs	I MDR	EUDAMED record Report an error
Receiving units for cardiotocographic telemetry	Z1208010402	Novii+ Interface2 refs	IIb MDR	EUDAMED record Report an error
Temperature monitoring cutaneous probes	V03010201	Lullaby Reusable Infant Temperature Probe 2044384-001	I MDR	EUDAMED record Report an error

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