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PN841

by Respironics Inc. 4 variants

Ref 1130573

PN841 (1130573) is a device classified as Class IIa in the EU and Class II in the US made by Respironics Inc., registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI B-00606959041721) and listed in FDA GUDID since 14 Mar 2017 (UDI-DI 00606959041721), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00606959041721 Basic UDI-DI 00606959041721UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959041721 UDI-DI Date14 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00606959041721 registered 22 Jul 2026 Active
  • FDA GUDID UDI-DI 00606959041721 listed 14 Mar 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00606959041721
  2. Registered EUDAMED B-00606959041721

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
PN841 Mask, INTL, Child Small, Leak 3, ASM EUDAMED
PN841 GUDID
Generic name
CPAP/BPAP nasal mask, single-use
Model / Ref / Catalog
1130573, PN841 Mask, INTL, Child Small, Leak 3, ASM
Primary DI / UDI-DI
00606959041721
Basic UDI-DI
B-00606959041721
FDA product code
BZD
EMDN code
R0301010201 Cpap masks
GMDN term
CPAP/BPAP nasal mask, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5905
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1130573
GUDID
PN841 Mask, INTL, Child Small, Leak 3, ASM
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: CPAP/BPAP nasal mask, single-use

Similar devices in this category

Other devices filed under CPAP MASKS.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)