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EasyOne Filter SP 2091-412

by NDD Medizintechnik AG

Ref 2091-412

EasyOne Filter SP 2091-412 is a pulmonary function testing filter/mouthpiece (EU MDR Class I; FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by NDD Medizintechnik AG, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 764014219Filter2J), cleared under FDA 510(k) K221250 on 22 Nov 2022 and listed in FDA GUDID since 9 Dec 2022 (UDI-DI 07640142190882), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K221250

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014219Filter2J Basic UDI-DI 07640142190882UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640142190882 UDI-DI Date9 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221250 Date22 Nov 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764014219Filter2J registered 13 May 2026 Active
  • FDA 510(k) K221250 decided 22 Nov 2022 Active
  • FDA GUDID UDI-DI 07640142190882 listed 9 Dec 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K221250
  2. Listed FDA GUDID 07640142190882
  3. Registered EUDAMED 764014219Filter2J

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
EasyOne Filter SP, 100 pcs EUDAMED
EasyOne Filter SP GUDID
Generic name
Pulmonary function testing filter/mouthpiece
Device name
Filter
Model / reference
2091-412
Primary DI / UDI-DI
07640142190882
Basic UDI-DI
764014219Filter2J
Direct marketing DI
07640142190882
510(k) Number
FDA product code
CAH
EMDN code
Z12150185 Spirometry instruments - consumables
GMDN term
Pulmonary function testing filter/mouthpiece
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5260
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Pulmonary function testing filter/mouthpiece

Cleared under the same submission (K221250)

Similar devices in this category

Other devices filed under SPIROMETRY INSTRUMENTS.

Other devices from NDD Medizintechnik AG

See all devices from NDD Medizintechnik AG →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)