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MEDUVISION Set Mac

by HEINE Optotechnik GmbH & Co. KG

Ref WM 10411

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4053755_VL-S_02_R7 Basic UDI-DI 04053755213092UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053755213092 UDI-DI Date23 Jun 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Video intubation laryngoscope handle/monitor
Model / Ref / Catalog
WM 10411, 000
Primary DI / UDI-DI
04053755213092
Basic UDI-DI
4053755_VL-S_02_R7
FDA Product Code
CCW
EMDN Code
Z12021004 Video laryngoscopes
GMDN Term
Video intubation laryngoscope handle/monitor
Device Class
Class I
Regulation Number
868.5540
Medical Purpose
This is a collection of devices intended for use by physicians to help them perform endotracheal intubation and an direct/indirect pharyngoscopy and laryngoscopy.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
WM 10411
GUDID
000

Manufacturer details

EUDAMED SRN
DE-PR-000035500

Other devices from Heine Optotechnik GmbH & Co. KG

See all devices from Heine Optotechnik GmbH & Co. KG →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No