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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

ClinRep® — IVDD — General IVDD by RECIPE Chemicals +…

MD Atlas
RECIPE Chemicals + Instruments GmbH

EUDAMED last updated this device on Apr 25, 2024

ClinRep®

B-6000A9

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: RECIPE Chemicals + Instruments GmbH
UDI-DI code: D-6000A9
Reference / catalog number: 6000

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Manufacturer information

Organization name: RECIPE Chemicals + Instruments GmbH
SRN: DE-MF-000032553
Manufacturer status: Active

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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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
See IFU sections 2.1.1 - 2.1.3

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: ClinRep®
UDI-DI code: D-6000A9
Basic UDI-DI: B-6000A9
Reference / catalog number: 6000
Issuing entity: EUDAMED

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: This ClinRep® Complete Kit is intended for the determination of serotonin from human plasma and serum with HPLC. The kit components have to be used in accordance with corresponding user manual. The kit is not designed for combination with components from other manufacturers.
Additional information URL: https://recipe.de/myrecipe
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102039011SEROTONINE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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