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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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RESOLVE Hb Elution Solution — 2 UDI-DI variants, IVDR (Wallac Oy)

MD Atlas
Wallac Oy

Data from EUDAMED, last updated May 23, 2026

RESOLVE Hb Elution Solution

6438147RESOLVE_HbElutJK

2 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: Wallac Oy

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 6438147RESOLVE_HbElutJK
Device name: RESOLVE Hb Elution Solution
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Mar 13, 2026

Manufacturer & authorised representative

Manufacturer

Name: Wallac Oy
SRN: FI-MF-000022620
Country: Finland
Email: regulatoryaffairs.turku@revvity.com
Phone: +3582 2678111

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G51GKBC9YXHY2VHEMB2H877A

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

RESOLVE Hb Elution Solution06438147246120
RESOLVE Hb Elution Solution06438147246137