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Organization name
UDI-DI code
Reference / catalog number

Accu-Chek Mobile — IVDD — Annex II List B IVDD

MD Atlas
Roche Diabetes Care GmbH

EUDAMED last updated this device on Aug 29, 2022

Accu-Chek Mobile

B-04015630063161

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Roche Diabetes Care GmbH
UDI-DI code: 04015630063161
Reference / catalog number: 06383602057

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Manufacturer information

Organization name: Roche Diabetes Care GmbH
SRN: DE-MF-000006276
Manufacturer status: Active

Related devices

Accu-ChekB-04015630070732On the market Accu-Chek AvivaB-04015630063505On the market Accu-Chek GuideB-08116113370HHOn the market Accu-Chek InsightB-04015630888139On the market Accu-Chek InstantB-04015630083435On the market

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 Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Finland		Still on market
Sweden		Still on market

Device identification

Trade name: Accu-Chek Mobile
UDI-DI code: 04015630063161
Basic UDI-DI: B-04015630063161
Reference / catalog number: 06383602057
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
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 Accu-Chek Mobile blood glucose meter is intended tobe used for quantitatvie blood glucose tests in human blood. It is suitable for patient self-testing only
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1204011502INVASIVE BLOOD SUGAR MONITORING SYSTEMS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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