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MEDUVISION Mac 3 (10x) 000

by Heine Optotechnik GmbH & Co. KG

Ref 237505Model MEDUVISION

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4053755_VLB_02_FZ Basic UDI-DI 04053755213108UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053755213108 UDI-DI Date23 Jun 2026ListedStatusListed 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  • Withdrawn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
MEDUVISION Mac 3 EUDAMED
MEDUVISION Mac 3 (10x) GUDID
Generic Name
Laryngoscope blade, single-use
Model / Ref / Catalog
MEDUVISION EUDAMED
237505 EUDAMED
000 GUDID
WM 10413 GUDID
Primary DI / UDI-DI
04053755213108
Basic UDI-DI
4053755_VLB_02_FZ
FDA Product Code
CCW
EMDN Code
R9002 Laryngoscope blades, single-use
GMDN Term
Laryngoscope blade, single-use
Device Class
Class I
Regulation Number
868.5540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MEDUVISION
237505
GUDID
000

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No