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Organization name
UDI-DI code
Reference / catalog number

MicroSight® MSI 1-Step HRM Analysis — IVDR Class C IVDR

MD Atlas
PentaBase A/S

EUDAMED last updated this device on Feb 11, 2026

MicroSight® MSI 1-Step HRM Analysis

5713915MS001SZ

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: PentaBase A/S
UDI-DI code: 05713915000441
Reference / catalog number: 7201

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Manufacturer information

Organization name: PentaBase A/S
SRN: DK-MF-000023157
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW266
EUDAMED did not publish a description for this code.
CW009
The buffers, primer/probe, and tubes are not to be reused
CW036
MicroSight® MSI 1-step HRM Analysis can only be run on a BaseTyper™ 48.4, a Gentier or a MyGo PCR RealTime PCR System

Market distribution

Primary placement in Denmark; available across 2 countries total.

Country	On market since	Until
DenmarkPrimary placement		Still on market
Türkiye		Still on market

Device identification

Trade name: MicroSight® MSI 1-Step HRM Analysis
UDI-DI code: 05713915000441
Basic UDI-DI: 5713915MS001SZ
Reference / catalog number: 7201
Issuing entity: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 16
Additional product description: MicroSight® MSI 1-step HRM Analysis is an in vitro diagnostic medical device designed to qualitatively detect microsatellite stability (MSS) or instability (MSI) through the analysis of mutations in five mononucleotide loci (BAT25, BAT26, NR22, NR24, and MONO27) using a semi-automated real-time polymerase chain reaction (qPCR) followed by high-resolution melting (HRM) analysis. MicroSight® MSI 1-step HRM Analysis is specifically intended for use with human DNA extracted from biopsies from solid tumors, including formalin-fixed paraffin-embedded (FFPE) tissue. The MicroSight® MSI 1-step HRM Analysis is intended to aid in diagnosing deficiencies in the mismatch repair (MMR) system through the analysis of microsatellite stability and instability in patients diagnosed with colorectal or endometrial cancer. MicroSight® MSI 1-step HRM Analysis is intended for use with patients already diagnosed with cancer who may benefit from additional genetic testing, to diagnose Lynch syndrome. Test results obtained using the product must be interpreted by healthcare professionals with other clinical findings, family history and laboratory data. It is not intended as a companion diagnostic device. The assay is intended for use by healthcare professionals, or qualified laboratory personnel, proficient in handling biological samples and specifically instructed and trained in the techniques of real-time PCR and HRM measurements.
Additional information URL: https://5ba.se/ms001
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01060214COLORECTAL CANCER (MSI-H / DMMR)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

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