Data / Medical devices / Device, Pasteurization, Hot Water
Device, Pasteurization, Hot Water (LDS): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Device, Pasteurization, Hot Water (product code LDS, Class 2, 21 CFR 880.6991). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on September 9, 2019, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LDS
- Device class
- 2
- Regulation
- 880.6991
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| Italy | 3 |
| Canada | 2 |
| United States | 1 |
| Switzerland | 1 |
| Israel | 1 |
Makers of Device, Pasteurization, Hot Water
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cenorin, LLC | Kent, WA, United States | Manufacturer | 2 | September 9, 2019 | 0 | 5 | 0 | api.fda.gov |
| At-Os S.R.L. | COLOGNOLA AI COLLI Verona, Italy | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cefla S.C. | IMOLA Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dent4you AG | Heerbrugg Sankt Gallen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scican Ltd. | TORONTO Ontario, Canada | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientek Technology Corporation | Delta British Columbia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tuttnauer Ltd. | BEIT SHEMESH Jerusalem, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Sterilization S.R.L. | BRUSAPORTO Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 9, 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.