Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

OneTouch Select Plus test strip — IVDD — Annex II List B IVDD

MD Atlas
LifeScan Europe GmbH

EUDAMED last updated this device on May 24, 2022

OneTouch Select Plus test strip

B-07613427004211

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: 07613427004211
Reference / catalog number: 023235

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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 Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Oct 18, 2018	May 26, 2026

Device identification

Trade name: OneTouch Select Plus test strip
UDI-DI code: 07613427004211
Basic UDI-DI: B-07613427004211
Reference / catalog number: 023235
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: OTSP Strip 1x50 IT
Additional information URL: https://www.onetouch.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101060101GLUCOSE TEST STRIPS

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

Related devices

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.