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Performax

by Respironics Inc. 28 variants

Ref 1083086

Performax (1083086) 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-00606959008069) and listed in FDA GUDID since 4 Mar 2019 (UDI-DI 00606959008069), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00606959008069 Basic UDI-DI 00606959008069UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959008069 UDI-DI Date4 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00606959008069 registered 22 Jul 2026 Active
  • FDA GUDID UDI-DI 00606959008069 listed 4 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00606959008069
  2. Registered EUDAMED B-00606959008069

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  • Withdrawn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
XXS PerforMax SE, MPU, W/4 HDGR EUDAMED
Performax GUDID
Generic name
CPAP/BPAP face mask, reusable
Model / Ref / Catalog
1083086, PERFORMAX PEDIATRIC SE, MPU, W/4 PT HEADGEAR, XXSMALL
Primary DI / UDI-DI
00606959008069
Basic UDI-DI
B-00606959008069
FDA product code
CBK
EMDN code
R03010199 Ventilation masks - other
GMDN term
CPAP/BPAP face mask, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5895
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
1083086
GUDID
PERFORMAX PEDIATRIC SE, MPU, W/4 PT HEADGEAR, XXSMALL
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 face mask, reusable

Similar devices in this category

Other devices filed under VENTILATION MASKS - OTHER.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

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