Organization name

Ezisurg Medical Co., Ltd.

SRN

CN-MF-000006742

Manufacturer status

Active

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

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged

Primary placement in Germany; available across 32 countries total.

Trade name

easyEndo™ Single Use Bladeless Trocar

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.

06925776126546

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.

69257761001401XP

Reference / catalog number

PT1C15LF

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

• 15 MU50

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

• 06925776126546× 1 unitBase unit
  • 66925776126548× 6 units
    • 76925776126545× 8 units

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

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

• K01010101TROCAR STANDARD, SINGLE-USE

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.