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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

OneTouch Select Plus Flex — IVDD — Annex II List B IVDD

MD Atlas
LifeScan Europe GmbH

EUDAMED last updated this device on May 15, 2024

OneTouch Select Plus Flex

B-07613427042992

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: LifeScan Europe GmbH
UDI-DI code: 07613427042992
Reference / catalog number: 024355

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Manufacturer information

Organization name: LifeScan Europe GmbH
SRN: CH-MF-000014224
Manufacturer status: Active

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OneTouch Select Plus Control SolutionB-07613427001487On the market OneTouch Select Plus Control SolutionB-07613427005683On the market OneTouch Select Plus Control SolutionB-07613427018218On the market OneTouch Select Plus Control SolutionB-07613427004280On the market OneTouch Select Plus Control SolutionB-07613427007229On 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 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 22, 2024	Still on market

Device identification

Trade name: OneTouch Select Plus Flex
UDI-DI code: 07613427042992
Basic UDI-DI: B-07613427042992
Reference / catalog number: 024355
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: OTSPF Sys FOC mmol EMEA LED
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201060102BLOOD GLUCOSE METERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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