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OT8G

by Zumax Medical CO., LTD.

Ref 461E3000

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
United StatesGUDID listing GUDID Number06945095543800 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69450955otoscopeTK Basic UDI-DI 06945095543800UDI-DIDate12 Mar 2026RegisteredStatusActive

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  • Withdrawn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

Trade Name
OT8G EUDAMED
zumax GUDID
Generic Name
Otoscope, direct
Device Name
otoscope
Model / Ref / Catalog
461E3000, OT8G
Primary DI / UDI-DI
06945095543800
Basic UDI-DI
69450955otoscopeTK
FDA Product Code
ERA
EMDN Code
Z12149006 Direct outpatient otoscopes
GMDN Term
Otoscope, direct
Device Class
Class I
Regulation Number
874.4770
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
461E3000
GUDID
OT8G

Manufacturer details

EUDAMED SRN
CN-MF-000011126
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Zumax Medical Co., LTD

See all devices from Zumax Medical Co., LTD →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No