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Air Microphone Maj-2548

by Olympus Medical Systems Corporation

Ref N6217500

Air Microphone Maj-2548 (N6217500) is a device classified as Class I in the EU and Class II in the US made by Olympus Medical Systems Corporation, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 495317000190BP), cleared under FDA 510(k) K243380 on 3 Mar 2025 and listed in FDA GUDID since 17 Mar 2025 (UDI-DI 04953170458231), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243380

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number495317000190BP Basic UDI-DI 04953170458231UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170458231 UDI-DI Date17 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243380 Date3 Mar 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 495317000190BP registered 23 Oct 2026 Active
  • FDA 510(k) K243380 decided 3 Mar 2025 Active
  • FDA GUDID UDI-DI 04953170458231 listed 17 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243380
  2. Listed FDA GUDID 04953170458231
  3. Registered EUDAMED 495317000190BP

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  • Withdrawn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
Air Microphone, Throat Microphone Maj-2548 EUDAMED
Air Microphone GUDID
Generic name
Freestanding microphone
Device name
Throat Microphone
Model / Ref / Catalog
N6217500, MAJ-2548
Primary DI / UDI-DI
04953170458231
Basic UDI-DI
495317000190BP
510(k) Number
FDA product code
EOB, EOQ, NWB, EQL, NTN, HET
EMDN code
Z12020480 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories
GMDN term
Freestanding microphone
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4760, 874.4680, 876.1500, 874.4750, 884.1720
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N6217500
GUDID
MAJ-2548
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: Freestanding microphone

Cleared under the same submission (K243380)

and 1 more cleared under K243380

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)