EUDAMED device

Series oro-nasal masks

EUDAMED device 00817136027180 · Hans Rudolph Inc

Key facts

Primary DI 00817136027180
Device name Series oro-nasal masks
Reference or catalog number 171470
Model 6860; 7600; 7700
Manufacturer Hans Rudolph Inc
Manufacturer SRN US-MF-000004498
Risk class Class IIa
EMDN code R0301010201
EMDN description CPAP MASKS
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Dec 13, 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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