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Accu-Beam Malleable ENT Sterilization Tray

by Transamerican Technologies International

Ref 1056521M

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++B17705AK2 Basic UDI-DI B1771056521M0UDI-DIDate2 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB1771056521M0 UDI-DI Date13 Jul 2020ListedStatusListed 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  • Withdrawn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 Malleable ENT Sterilization Tray EUDAMED
Accu-Beam GUDID
Generic Name
Instrument tray, reusable
Device Name
Accu-Beam Fiber Optic Handpiece Accessories
Model / Reference
1056521M
Primary DI / UDI-DI
B1771056521M0
Basic UDI-DI
++B17705AK2
Direct Marketing DI
B1771056521M0
FDA Product Code
FSM
EMDN Code
L80 Surgical instruments, reusable - various accessories
GMDN Term
Instrument tray, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

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

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