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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

K 7730H — IVDD — General IVDD by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on May 26, 2026

K 7730H

B-04050598008878

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598008878
Reference / catalog number: K 7730H

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View device family (Basic UDI)

Manufacturer information

Organization name: Immundiagnostik AG
SRN: DE-MF-000020905
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

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

CW043
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04050598008878
Basic UDI-DI: B-04050598008878
Reference / catalog number: K 7730H
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: This Immundiagnostik AG assay is intended for the quantitative determination of L-tryptophan in human EDTA plasma, serum and dried blood spots. For in vitro diagnostic use only. For rodent specimens (mouse, rat) and for cell culture supernatant and CSF we recommend our IDK® Tryptophan high sensitive ELISA KR3730.
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)04050598008878

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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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