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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

505-50 — IVDD — General IVDD by Pentapharm AG

MD Atlas
Pentapharm AG

EUDAMED last updated this device on Mar 10, 2026

505-50

B-07640175460068

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Pentapharm AG
UDI-DI code: 07640175460068
Reference / catalog number: 505-50

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Manufacturer information

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

Critical warnings

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

CW267
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW306
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 07640175460068
Basic UDI-DI: B-07640175460068
Reference / catalog number: 505-50
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: Pefaclot® UFH is a plasma based functional clotting assay for the quantitative determination of the anticoagulant activity of UFH, based on factor Xa and/or IIa inhibition. 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)

W0103020104ACTIVATED CLOTTING TIME

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.