Data / Medical devices / Apparatus, Melting Point, Paraffin
Apparatus, Melting Point, Paraffin (IDT): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Apparatus, Melting Point, Paraffin (product code IDT, Class 1, 21 CFR 864.3010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IDT
- Device class
- 1
- Regulation
- 864.3010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| China | 2 |
| United States | 2 |
| United Kingdom | 1 |
| Germany | 1 |
Makers of Apparatus, Melting Point, Paraffin
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 |
|---|---|---|---|---|---|---|---|---|
| Cellpath Ltd | NEWTOWN Powys, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | Marlborough, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Youding International Trade Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| pfm medical mepro gmbh | Nonnweiler-Otzenhausen Saarland, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.