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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

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

MD Atlas
RECIPE Chemicals + Instruments GmbH

EUDAMED last updated this device on Apr 25, 2024

ClinEasy®

B-17300FR

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-17300FR
Reference / catalog number: 17300

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Manufacturer information

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

Critical warnings

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

CW018
See IFU sections 2.1.3 - 2.1.5

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: ClinEasy®
UDI-DI code: D-17300FR
Basic UDI-DI: B-17300FR
Reference / catalog number: 17300
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 ClinEasy® Complete Kit is intended for the photometric quantitative determination of porphobilinogen in urin. 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)

W01010225PORPHOBILINOGEN

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.