200100

Organization name

Tem Innovations GmbH

SRN

DE-MF-000012176

Manufacturer status

Active

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

• CW010

  Indicates the need for the user to consult the instructions for use.
• CW011

  Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

Primary placement in Austria; available across 32 countries total.

Trade name

not provided

UDI-DI code

04260160470020

Basic UDI-DI

4260160470020QR

Reference / catalog number

200100

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0202029001THROMBELASTOGRAPHS

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