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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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Organization name
UDI-DI code
Reference / catalog number

APCr — IVDR Class B IVDR by Pentapharm AG

MD Atlas
Pentapharm AG

EUDAMED last updated this device on Jan 22, 2026

APCr

76401754608013934190QZ

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Pentapharm AG
UDI-DI code: 07640175460099
Reference / catalog number: 08013934190

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Manufacturer information

Organization name: Pentapharm AG
SRN: CH-MF-000020620
Manufacturer status: Active

Critical warnings

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

CW010
Online
CW076
EUDAMED did not publish a description for this code.
CW088
EUDAMED did not publish a description for this code.
CW102
EUDAMED did not publish a description for this code.
CW158
EUDAMED did not publish a description for this code.
CW162
EUDAMED did not publish a description for this code.
CW163
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW044
EUDAMED did not publish a description for this code.
CW263
EUDAMED did not publish a description for this code.
CW267
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 22, 2026	Still on market

Device identification

Trade name: APCr
UDI-DI code: 07640175460099
Basic UDI-DI: 76401754608013934190QZ
Reference / catalog number: 08013934190
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: APC Resistance (APCr) is an in vitro assay for the qualitative determination of resistance of Factor Va to inactivation by activated protein C (APC). APCr is intended for the automatic processing of citrated plasma on the indicated cobas t analyzers. The assay is intended as aid to diagnosis of factor V Leiden mutation (FV:R506Q).
Additional information URL: https://navifyportal.roche.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103020610APC RESISTANCE

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

Related devices

08013934190B-07613336155448On the market 0804523219076401754608045232190QKOn the market 08045232190B-07613336155455On the market Batroxobin TimeB-07640175460037On the market 505-60B-07640175460075On the market

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.