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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

FD-N-DCH-20 — IVDD — General IVDD by FROST Diagnostika GmbH

MD Atlas
FROST Diagnostika GmbH

EUDAMED last updated this device on May 26, 2026

FD-N-DCH-20

B-04262550791012

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: FROST Diagnostika GmbH
UDI-DI code: 04262550791012
Reference / catalog number: FD-N-DCH-20

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View device family (Basic UDI)

Manufacturer information

Organization name: FROST Diagnostika GmbH
SRN: DE-MF-000034832
Manufacturer status: Active

Critical warnings

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

CW010
siehe IFU

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 1, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262550791012
Basic UDI-DI: B-04262550791012
Reference / catalog number: FD-N-DCH-20
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: immunologischer Dreifach-Kassetten Schnelltest zum Nachweis von Hämoglobin, Hämoglobin/Haptoglobin Komplex und Calprotectin in der Stuhlprobe
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04262550791012

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0102019099SPECIFIC PROTEINS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

This device is not currently linked to any other device.

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.