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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

08045232190 — IVDR Class B IVDR by Pentapharm AG

MD Atlas
Pentapharm AG

EUDAMED last updated this device on Jan 22, 2026

08045232190

76401754608045232190QK

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: 07640175460105
Reference / catalog number: 08045232190

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Manufacturer information

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

Critical warnings

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

CW010
Online
CW263
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: not provided
UDI-DI code: 07640175460105
Basic UDI-DI: 76401754608045232190QK
Reference / catalog number: 08045232190
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 Controls (APCr Controls) are used for quality control of the APC Resistance assay on indicated cobas t analyzers.
Additional information URL: https://navifyportal.roche.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103020702CONTROL PLASMA FOR HAEMOSTASIS

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 APCr76401754608013934190QZOn 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.