OneTouch Delica Safety

Organization name

Asahi Polyslider Company, Limited

SRN

JP-MF-000009245

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW009

  Do not reuse to reduce the risk of infection.
• CW007

  Do not use if the package seals are missing or broken, or if the cap is loose, missing, or has been removed.

Primary placement in Austria; available across 7 countries total.

Trade name

OneTouch Delica Safety

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04580505780493

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

458050578OTDSHJ

Reference / catalog number

024-208

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

200

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 30G

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V010401LANCETS WITH SAFETY SYSTEMS, SINGLE-USE

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.