Data / Medical devices / Belgium / Terumo BCT Europe N.V.
Terumo BCT Europe N.V.: FDA-registered device maker in Leuven Vlaams Brabant, Belgium, 1 510(k) clearance
Terumo BCT Europe N.V. is registered with the FDA (registration 3010425916) in Leuven Vlaams Brabant, Belgium. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010425916
- Address
- Medical Electronics Romeinsestraat 8, Leuven Vlaams Brabant, Belgium, B-3001
- Owner or operator
- Terumo BCT, INC. (9002708)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- November 30, 1993
- Registered through
- 2026
- Brand names listed
- Astoline, Astotherm Plus, Astotubes, T-SEAL II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Heat-Sealing | KSD | 1 | Contract manufacturer | accessdata.fda.gov |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 2, 1999 | K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | BSB | Substantially Equivalent | Stihler Electronic GmbH | accessdata.fda.gov |
Compare with other makers
Updated September 2, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.