SP-WELL-A

Organization name

Seramun Diagnostica GmbH

SRN

DE-MF-000026029

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 17 countries total.

Trade name

not provided

UDI-DI code

04099466360519

Basic UDI-DI

4099466SPWELLAX

Reference / catalog number

SP-WELL-A

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

Device for image acquisition of SeraSpot® tests in 8-well strips or single wells of a 96-well microtiter plate.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0299IVD INSTRUMENTS - OTHER

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

Certificate health across this manufacturer's portfolio.