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Instrument Case / Tray

by Avalign Technologies Inc. 25 variants

Ref 811497

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 Number0190776TRAYSZE Basic UDI-DI 00190776023591UDI-DIDate5 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776023591 UDI-DI Date23 Mar 2017ListedStatusListed 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  • Withdrawn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
Avalign
Generic Name
Device sterilization/disinfection container, reusable
Device Name
Instrument Case / Tray
Model / Reference
811497
Primary DI / UDI-DI
00190776023591
Basic UDI-DI
0190776TRAYSZE
Direct Marketing DI
00190776023591
FDA Product Code
KCT
EMDN Code
V0402 Clinical use trays and bowls
GMDN Term
Device sterilization/disinfection container, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Width — 3.23 Inch
Length — 20.87 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008511
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from AVALIGN TECHNOLOGIES, Inc.

See all devices from AVALIGN TECHNOLOGIES, Inc. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No