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spirette m 2050-7

by NDD Medizintechnik AG

Ref 2050-7

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014219BreathingTubes6L Basic UDI-DI 07640142190271UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640142190271 UDI-DI Date23 Jun 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Spirette M (basic unit) EUDAMED
spirette m GUDID
Generic Name
Pulmonary function testing filter/mouthpiece
Device Name
Breathing tubes
Model / Reference
2050-7
Primary DI / UDI-DI
07640142190271
Basic UDI-DI
764014219BreathingTubes6L
FDA Product Code
BYP
EMDN Code
Z12150185 Spirometry instruments - consumables
GMDN Term
Pulmonary function testing filter/mouthpiece
Device Class
Class I
Regulation Number
868.5620
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Other devices from NDD Medizintechnik AG

See all devices from NDD Medizintechnik AG →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No