Organization name

BIP Biomedizinische Instrumente und Produkte GmbH

SRN

DE-MF-000010311

Manufacturer status

Active

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

• Do not resterilize
• Do not use if package is damaged
• Do not re-use
• Consult instructions for use
• Caution
• Do not use past indicated date

Primary placement in Germany; available across 25 countries total.

Trade name

BIP HistoCore® T Biopsy Device, disposable

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.

04251135801512

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.

42511358000001DL

Reference / catalog number

HC12100T

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

https://www.bipmedical.com/ifu

Clinical sizes

• 12 Gauge (G)
• 100 MU50
• WingTip-Trocar®
• Notch Width — 19 MU50

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

• 04251135801512× 1 unitBase unit
  • 04251135801529× 5 units

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

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

• A0102010102SHEARING BIOPSY GUNS
• A0102010101SHEARING BIOPSY NEEDLES

• Class IIa medical devices in EUDAMED

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