Organization name

B. Braun Melsungen AG

SRN

DE-MF-000000201

Manufacturer status

Active

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

• Do not re-use
• Do not use past indicated date
• Do not use if package is damaged

Primary placement in Germany; available across 27 countries total.

Trade name

Omnifix® 100 Solo

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.

04022495289964

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.

403923900000121925

Reference / catalog number

9161708V

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

OMNIFIX 1 ML INSULIN 100 I.U.

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

• 1 ML

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

• 04022495289964× 1 unitBase unit
  • 04022495281869× 100 units
    • 04022495281876× 18 units

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

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

• A02010602INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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