7639

Trade name

not provided

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.

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08012992437094

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.

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B-08012992437094

Reference / catalog number

7639

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.

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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.

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Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Securlancets Unik safety lancets type 520 are sterile, single use medical devices intended for capillary blood sampling.

Additional information URL

https://htl-strefa.com/products/safety-lancets/medisafe-solo/

Clinical sizes

• 0.5 MU50
• Penetration depth — 1.5 MU50

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

• V010401LANCETS WITH SAFETY SYSTEMS, SINGLE-USE

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

• CW001

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

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