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AccuPAP 313-6001

by Pulmodyne Inc.

Ref 313-6001

AccuPAP 313-6001 is a device classified as Class IIa in the EU and Class II in the US made by Pulmodyne Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00841470103156) and listed in FDA GUDID since 24 Aug 2018 (UDI-DI 00841470103156), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841470103156 Basic UDI-DI 00841470103156UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841470103156 UDI-DI Date24 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841470103156 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00841470103156 listed 24 Aug 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841470103156
  2. Registered EUDAMED B-00841470103156

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  • Withdrawn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
AccuPAP
Generic name
In-line CPAP set, non-nebulizing
Model / reference
313-6001
Primary DI / UDI-DI
00841470103156
Basic UDI-DI
B-00841470103156
FDA product code
BYE
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
In-line CPAP set, non-nebulizing
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5965
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: In-line CPAP set, non-nebulizing

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Pulmodyne Inc.

See all devices from Pulmodyne Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)