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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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PlentiPlex™ MYD88 Waldenström Lymphoma… — 2 UDI-DI variants, IVDR

MD Atlas
PentaBase A/S

Data from EUDAMED, last updated May 23, 2026

PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay

5713915PP004TK

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: PentaBase A/S

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Device characteristics

ReagentProfessional testingHuman tissues / cells

Clinical investigations

Registered: No

Identity & classification

Basic UDI-DI: 5713915PP004TK
Device name: PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay
Device model: PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Feb 15, 2026

Manufacturer & authorised representative

Manufacturer

Name: PentaBase A/S
SRN: DK-MF-000023157
Country: Denmark
Email: info@pentabase.com
Phone: +45 36 96 94 96

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KHGS18QGKGFH06NVNKHXMY5W

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

PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay05713915000410
PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay05713915000427