Organization name

TSK Laboratory, Japan

SRN

JP-MF-000008485

Manufacturer status

Active

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

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

Primary placement in Italy; available across 32 countries total.

Trade name

TSK ACECUT BIOPSY NEEDLE

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.

04580708050331

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.

4571225300002U8

Reference / catalog number

ACE-162002

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

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 16G
• 200 MU50
• 22 MU50

1 packaging level registered — each level carries its own UDI-DI.

• 04580708050331× 1 unitBase unit
  • 14580708050338× 10 units

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

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

• A0102010101SHEARING BIOPSY NEEDLES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.