EUDAMED device

Pediatric Mask - Small

EUDAMED device 00383730001135 · Respironics Inc.

Key facts

Primary DI 00383730001135
Trade name Pediatric Mask - Small
Device name Silicone Face Mask
Reference or catalog number HS81110EU-001
Manufacturer Respironics Inc.
Manufacturer SRN US-MF-000002301
Risk class Class I
EMDN code R030199
EMDN description RESPIRATORY MASKS - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Mar 20, 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:

Browse all EUDAMED devices