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Jaeger 892103

by Jaeger Medical GmbH

Ref 892103

Jaeger 892103 is a breathing mouthpiece (EU MDD Class IIa; FDA Class I; FDA product code BYP, Mouthpiece, Breathing) made by Jaeger Medical GmbH, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-14250892908080) and listed in FDA GUDID since 2 Jun 2025 (UDI-DI 14250892908080), 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-14250892908080 Basic UDI-DI 14250892908080UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14250892908080 UDI-DI Date2 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-14250892908080 registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 14250892908080 listed 2 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14250892908080
  2. Registered EUDAMED B-14250892908080

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  • Withdrawn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
Jaeger
Generic name
Breathing mouthpiece, single-use
Model / Ref / Catalog
892103
Primary DI / UDI-DI
14250892908080
Basic UDI-DI
B-14250892908080
FDA product code
BYP
EMDN code
R9001 Respiratory mouthpieces
GMDN term
Breathing mouthpiece, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5620
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Breathing mouthpiece, single-use

Similar devices in this category

Other devices filed under RESPIRATORY MOUTHPIECES.

Other devices from Jaeger Medical GmbH

See all devices from Jaeger Medical GmbH →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)