EUDAMED device

BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL

EUDAMED device 00606959029637 · Respironics Inc.

Key facts

Primary DI 00606959029637
Trade name BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL
Reference or catalog number IN961HS
Model BiPAP autoSV Advanced System One
Manufacturer Respironics Inc.
Manufacturer SRN US-MF-000002301
Risk class Class IIb
EMDN code Z12030102
EMDN description CONTINUOUS POSITIVE PRESSURE EQUIPMENT
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Jul 17, 2025

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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