Data / Medical devices / Switzerland / Belimed AG
Belimed AG: FDA-registered device maker in Zug, Switzerland, 10 510(k) clearances
Belimed AG is registered with the FDA (registration 3001061128) in Zug, Switzerland. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 31, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3001061128
- Address
- Grienbachstrasse 11, Zug, Switzerland, 6300
- Owner or operator
- Belimed AG (10052111)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- June 15, 2016
- Registered through
- 2027
- Brand names listed
- Belimed Steam Sterilizer MST-H Top 5000, Belimed Steam Sterilizer MST-H, Models: MST-H 9-6-12 HS1/HS2 MST-H 9-6-15 HS1/HS2 MST-H 9-6-18 HS1/HS2, Belimed TOP 5000 Series 24. GR15-6-18HS1/GR15-6-18HS2, Belimed TOP 5000 Series 4-8. 6-0-6VS1/VS2, 6-0-9VS1/VS2, 6-0-12VS1/VS2, Belimed TOP 5000 Series 5-5-9VS1/VS2, 5-0-9VS1/VS2, Belimed TOP 5000. 9-6-9HS1/HS2, GR9-6-9HS1/HS2, 9-6-12HS1/HS2, GR9-6-12HS1/HS2, 9-6-15HS1/HS2, GR9-6-15HS1/HS2, 9-6-18HS1/HS2, GR9-6-18HS1/HS2, CS 750, Cart Washer, Enzymatic Detergent Washer Disinfector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 31, 2019 | K191896 | Belimed Steam Sterilizer MST-H TOP 5000 | FLE | Substantially Equivalent | Belimed AG | accessdata.fda.gov |
| May 12, 2017 | K170228 | Belimed Steam Sterilizer MST-H TOP 5000 | FLE | Substantially Equivalent | Belimed AG | accessdata.fda.gov |
| June 17, 2015 | K141879 | BELIMED STEAM STERILIZER MST-H | FLE | Substantially Equivalent | Sauter AG | accessdata.fda.gov |
| March 15, 2011 | K103841 | BELIMED STEAM STERILIZER MST-V | FLE | Substantially Equivalent | Sauter AG | accessdata.fda.gov |
| August 27, 2010 | K100622 | BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 | FLE | Substantially Equivalent | Belimed Sauter AG | accessdata.fda.gov |
| September 23, 2009 | K090339 | BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 | FLE | Substantially Equivalent | Belimed Sauter AG | accessdata.fda.gov |
| October 5, 2007 | K072087 | BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 | FLE | Substantially Equivalent | Belimed Sauter AG | accessdata.fda.gov |
| March 8, 2006 | K060337 | BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 | FLE | Substantially Equivalent | Sauter AG | accessdata.fda.gov |
| February 2, 2004 | K033538 | BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 | FLE | Substantially Equivalent | Sauter AG | accessdata.fda.gov |
| June 26, 2002 | K021223 | BELIMED STEAM STERILIZER, MODEL TOP 5000 | FLE | Substantially Equivalent | Sauter AG | accessdata.fda.gov |
Compare with other makers
- All makers of Disinfector, Medical Devices
- All makers of Sterilizer, Steam
- All makers of Cleaner, Ultrasonic, Medical Instrument
Updated October 31, 2019. 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.