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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

Atlas Home Diabetes test — IVDD — Self-testing IVDD

MD Atlas
Atlas Medical GmbH

EUDAMED last updated this device on Jun 30, 2023

Atlas Home Diabetes test

B-04260658550005

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: 04260658550005
Reference / catalog number: 70004001

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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 Diabetes test
UDI-DI code: 04260658550005
Basic UDI-DI: B-04260658550005
Reference / catalog number: 70004001
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: The Atlas Diabetic Check kit contains dip-and-read test strips and is intended for use to check for glucose and ketones levels in urine specimens as an aid in diagnosing diabetes. The test provides results by the visual comparison with a colour chart printed on the pouch. Each colour denotes a range of concentrations of glucose and ketones.
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.