Organization name

B. Braun Medical AG

SRN

CH-MF-000017781

Manufacturer status

Active

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

• Do not use past indicated date
• H412 – Harmful to aquatic life with long lasting effects.
• P273 – Avoid release to the environment.
• H318 – Causes serious eye damage.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.

Primary placement in Germany; available across 27 countries total.

Trade name

Helizyme®

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.

07612449083402

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.

4039239000000063ZL

Reference / catalog number

18767

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

HELIZYME CANISTER "WEST" 5LT

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

• 5 L

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

• 07612449083402× 1 unitBase unit
  • 07612449083440× 128 units

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

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

• V0799PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.