ACS-001

Organization name

Seramun Diagnostica GmbH

SRN

DE-MF-000026029

Manufacturer status

Active

3 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.
• CW009

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 9 countries total.

Trade name

not provided

UDI-DI code

04099466400116

Basic UDI-DI

4099466ACS001NW

Reference / catalog number

ACS-001

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

Stool Preparation Kit for the extraction of pancreatic elastase from stool samples of human origin for use with the IVD product Pancreatic Elastase ELISA

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.

• W05019001FAECES COLLECTION DEVICES

Certificate health across this manufacturer's portfolio.