Data / Medical devices / Italy / HMC Premedical S.p.A.
HMC Premedical S.p.A.: FDA-registered device maker in MIRANDOLA Modena, Italy, 2 510(k) clearances
HMC Premedical S.p.A. is registered with the FDA (registration 9613419) in MIRANDOLA Modena, Italy. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613419
- FEI number
- 3000168341
- Address
- Via Bosco 1/3, MIRANDOLA Modena, Italy, 41037
- Owner or operator
- HMC Group (9041724)
- Roles
- Manufacturer
- First device listed
- May 5, 2006
- Registered through
- 2026
- Brand names listed
- B-SMART, B-SMART PRESSURE MANOMETER, BA01BL ENFit Stepped Bottle Adapter - Bulk, BA01L ENFit Stepped Bottle Adapter, BA02BL ENFit Bottle Adapter 15mm-16.5mm - Bulk, BA02L ENFit Bottle Adapter 15mm-16.5mm, BA03BL ENFit Bottle Adapter 18mm-19.5mm - Bulk, BA03L ENFit Bottle Adapter 18mm-19.5mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anesthesia Conduction Kit | CAZ | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 18, 2025 | K242917 | Enteral Drainage System, Enteral Medicine straw | PIF | Substantially Equivalent | HMC Premedical S.p.A. | accessdata.fda.gov |
| January 15, 2004 | K031128 | B-SMART, MODEL B-01 | CAZ | Substantially Equivalent | Macosta Medical USA, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dispenser, Liquid Medication
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Anesthesia Conduction Kit
Updated June 18, 2025. 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.