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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

502-01 — IVDD — General IVDD by Pentapharm AG

MD Atlas
Pentapharm AG

EUDAMED last updated this device on Apr 22, 2026

502-01

B-07640175460044

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Pentapharm AG
UDI-DI code: 07640175460044
Reference / catalog number: 502-01

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Manufacturer information

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

Critical warnings

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

CW008
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.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 19, 2004	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07640175460044
Basic UDI-DI: B-07640175460044
Reference / catalog number: 502-01
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Pefakit® APC-R Factor V Leiden is a plasma-based functional assay for the qualitative determination of resistance to activated protein C (APC) caused by the Factor V Leiden mutation (FV:R506Q). The assay requires the use of a coagulation analyzer.
Additional information URL: No additional information URL provided by the manufacturer.
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

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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.