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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

800191 — IVDD — General IVDD by Pentapharm AG

MD Atlas
Pentapharm AG

EUDAMED last updated this device on Mar 23, 2023

800191

B-07640175460082

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Pentapharm AG
UDI-DI code: 07640175460082
Reference / catalog number: 800191

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Manufacturer information

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

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07640175460082
Basic UDI-DI: B-07640175460082
Reference / catalog number: 800191
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® Reptilase® Time is a plasma based functional assay intended to be used for the determination of the Reptilase® induced clotting time (= Reptilase® Time, RT) by a semi- or fully automated system.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103020103THROMBIN TIME / REPTILASE / BATROXBIN 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.