Organization name

B Medical Systems S.à r.l.

SRN

LU-MF-000000128

Manufacturer status

Active

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

• Do not use if package is damaged

  Described in instructions for use

• Consult instructions for use

  Related ISO15223-1 symbol mentioned on dataplate

• H221 – Flammable gas.

  Described in instructions for use

• P103 – Read label before use.

  Described in instructions for use

• P202 – Do not handle until all safety precautions have been read and understood.

  Described in instructions for use

• P282 – Wear cold insulating gloves/face shield/eye protection.

  Described in instructions for use

• P102 – Keep out of reach of children.

  Described in instructions for use

Primary placement in Austria; available across 32 countries total.

Trade name

F130

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.

05450104548215

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.

05450104511165AW

Reference / catalog number

991.8700.**

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

Laboratory freezers are devices intended to be used in health centers, hospitals, pharmacies, as well as in diagnostic and research laboratories for the support on the therapy and/or prevention of diseases by keeping pharmaceuticals, vaccines, cultures, test materials, chemicals, reagents, or other laboratory preparations at a protective and stable temperature in frozen state until they are ready for application or use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• V0899MEDICAL SUPPORT EQUIPMENT - OTHER

• Class I medical devices in EUDAMED

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