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Accu-Beam F13-28 Endoscope Coupler

by Transamerican Technologies International

Ref 8019I

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 Number++B177125V Basic UDI-DI B1778019I0UDI-DIDate6 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB1778019I0 UDI-DI Date29 Aug 2018ListedStatusListed 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  • Withdrawn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

Trade Name
Accu-Beam F13-28 Endoscope Coupler EUDAMED
Accu-Beam GUDID
Generic Name
Endoscope camera adaptor
Device Name
Accu-Beam Endoscopic Video Adaptors
Model / Reference
8019I
Primary DI / UDI-DI
B1778019I0
Basic UDI-DI
++B177125V
Direct Marketing DI
B1778019I0
FDA Product Code
FWL
EMDN Code
Z12020480 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories
GMDN Term
Endoscope camera adaptor
Device Class
Class I
Regulation Number
878.4160
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Hydrogen Peroxide

Manufacturer details

EUDAMED SRN
US-MF-000007955
Authorised representative
QNET B.V. NL-AR-000002695

From the manufacturer

Manufacturer's product page: Endoscope Couplers

Other devices from Transamerican Technologies International

See all devices from Transamerican Technologies International →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • 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
  • Manufacturing Date: No