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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

GlutenCHECK — IVDD — Self-testing IVDD by NanoRepro AG

MD Atlas
NanoRepro AG

EUDAMED last updated this device on Nov 11, 2024

GlutenCHECK

B-400600M9

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: NanoRepro AG
UDI-DI code: D-400600M9
Reference / catalog number: 400600

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Manufacturer information

Organization name: NanoRepro AG
SRN: DE-MF-000023735
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.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Portugal; available across 1 country total.

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

Device identification

Trade name: GlutenCHECK
UDI-DI code: D-400600M9
Basic UDI-DI: B-400600M9
Reference / catalog number: 400600
Issuing entity: EUDAMED

Classification

Risk category: IVDD — Self-testing
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Immunochromatographic rapid test for self-testing for the qualitative determination of anti-tTG IgA antibodies in human whole blood samples
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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