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Organization name
UDI-DI code
Reference / catalog number

Atlas Home Liver Function Test — IVDD — Self-testing IVDD

MD Atlas
Atlas Medical GmbH

EUDAMED last updated this device on Jun 30, 2023

Atlas Home Liver Function Test

B-04260658550012

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Atlas Medical GmbH
UDI-DI code: 04260658550012
Reference / catalog number: 70023001

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Manufacturer information

Organization name: Atlas Medical GmbH
SRN: DE-MF-000029961
Manufacturer status: Active

Critical warnings

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

CW010
Read the instructions for use before using the kit.

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: Atlas Home Liver Function Test
UDI-DI code: 04260658550012
Basic UDI-DI: B-04260658550012
Reference / catalog number: 70023001
Issuing entity: GS1

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: Liver Function Test provides dip-and-read test strips that are intended for use to check for bilirubin and urobilinogen in urine specimens as an aid in the diagnosis of liver and gallbladder problems. The test provides results by the visual comparison with a colour chart printed on the pack
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101060204URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)

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.