Identity
- Device Name
- Airborne TIS EUDAMED
- Model / Reference
- Airborne TIS EUDAMED050-7320000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649991187135 EUDAMED
- Basic UDI-DI
- 7649991187TISRW EUDAMED
- EMDN Code
- Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMED
Classification
- 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
Clinical & Handling
Sterile
No
EUDAMED
Airborne TIS by International Biomedical AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
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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Manufacturer
- Manufacturer
- International Biomedical AG
- EUDAMED SRN
- CH-PR-000040281
Sources (1)
- EUDAMED 49e9a544-01be-43c6-a4ed-eb7b7d8bd1f4 61 fields · synced Jun 17, 2026