Organization name

FUJIFILM medwork GmbH

SRN

DE-MF-000008444

Manufacturer status

Active

5 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
• Refer to instruction manual/booklet

Primary placement in Germany; available across 32 countries total.

Trade name

EUS1-B1-25

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.

04044503017871

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.

4044503017813S

Reference / catalog number

70100171410

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://med-lib.fujifilm.com/

Clinical sizes

• 25 Gauge needle size

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

• 04044503017871× 1 unitBase unit
  • 14044503017878× 1 unit

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

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

• G030899INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.