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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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AQUIOS Tetra — 2 UDI-DI variants, IVDR (Beckman Coulter Ireland Inc.)

MD Atlas
Beckman Coulter Ireland Inc.

Data from EUDAMED, last updated May 24, 2026

AQUIOS Tetra

150995902LSANTIBODYREARD

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class C

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Manufacturer: Beckman Coulter Ireland Inc.

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Device characteristics

ReagentAnimal tissues / cells

Identity & classification

Basic UDI-DI: 150995902LSANTIBODYREARD
Device name: AQUIOS Tetra
Device model: AQUIOS Tetra
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Oct 5, 2022

Manufacturer & authorised representative

Manufacturer

Name: Beckman Coulter Ireland Inc.
SRN: IE-MF-000000887
Country: Ireland
Email: ra.clare@beckman.com
Phone: +353 65 6831100

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01GEMY8GBV4CRRSBGKCW0H7R3K

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

AQUIOS Tetra-1 Panel15099590225704
AQUIOS Tetra-2+ Panel15099590225735