GEWF solution

Organization name

Reagena Oy

SRN

FI-MF-000002804

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW094

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW058

  EUDAMED did not publish a description for this code.
• CW093

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW083

  EUDAMED did not publish a description for this code.
• CW139

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW422

  EUDAMED did not publish a description for this code.
• CW313

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 32 countries total.

Trade name

GEWF solution

UDI-DI code

06430074451080

Basic UDI-DI

643007445102448AD

Reference / catalog number

192448

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

The GEWF solution is a ready-to-use fixative intended to enhance the visibility and yield of lymph nodes in surgical resection specimens.

Additional information URL

https://www.reagena.com/reagena-documents/

Clinical sizes

No clinical sizes registered for this device.

• W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

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

Certificate health across this manufacturer's portfolio.