00170-SS-bTECK

Organization name

TLA Targeted Immunotherapies AB

SRN

SE-MF-000039975

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  Single use only
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  Shelf life of device

Primary placement in Sweden; available across 1 country total.

Trade name

not provided

UDI-DI code

D-70-SS-bTECKAA

Basic UDI-DI

B-70-SS-bTECKAA

Reference / catalog number

00170-SS-bTECK

Issuing entity

EUDAMED

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

A hemoperfusion device intended for extracorporeal filtration of blood cells for the treatment of patients with inflammatory bowel disorders (IBD), specifically ulcerative colitis (UC). The TLA GUT device is a column consisting of a plastic container which in both ends carry luer plug connections that allow for connection with an apheresis machine intended for hemoperfusion, through a tubing set. The contents of the TLA GUT column are a matrix bead slurry to which a biologically active peptide has been coupled working as the ligand to the chemokine receptor CCR9, which is highly expressed on lymphocytes in patients with IBD. When the blood is passed through the TLA GUT column, blood cells of a specific disease-causing type are trapped by the chemokine-chemokine receptor interaction. The full blood volume, including the remaining un-bound blood cells, is subsequently returned to the patient through the other arm.

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

D-70-SS-bTECKAA

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• B030299APHERESIS THERAPY DEVICES - OTHER
• B030202CYTAPHERESIS DEVICES AND KITS

This device is not currently linked to any other device.