Airborne TIS

EUDAMED

Class IIb (EU MDR)

Ref 050-7320000Model Airborne TISRef 050-7320000

Identity

Primary DI / UDI-DI: 07649991187029 EUDAMED
07649991187111 EUDAMED
07649991187074 EUDAMED
07649991187692 EUDAMED
07649991187098 EUDAMED
07649991187050 EUDAMED
07649991187081 EUDAMED
07649991187678 EUDAMED
07649991187104 EUDAMED
07649991187036 EUDAMED
07649991187043 EUDAMED
Basic UDI-DI: 7649991187TISRW EUDAMED
EMDN Code: Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMED

Device Class: Class IIb EUDAMED
Medical Purpose: The Airborne TIS is a transport and mounting system designed for the safe accommodation and conveyance of neonates, infants, and children during ground‑ and air‑based patient transport. It is intended to accommodate an Airborne Transport Incubator (for the transport of critically ill neonates in a controlled environment) or, alternatively, a child seat or a pediatric stretcher. In addition, it enables the integration and fixation of respiratory gas supply systems, medical monitoring devices, pneumatic and electrical auxiliary equipment, as well as other medical and non‑medical devices and accessories. The device is intended for use on commercially available transport trolleys in ground ambulance services, as well as in helicopters and fixed‑wing aircraft used for air rescue, utilizing the designated mounting interfaces. The Airborne TIS serves exclusively to provide mechanical securing and stabilization of the components during transport and has no diagnostic or therapeutic function. EUDAMED

Sterile

EUDAMED

Airborne TIS by International Biomedical AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	7649991187TISRW	Class IIb	Active

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