FDA Registration
Active
🇮🇹 Italy
HMC Premedical S.p.A.
Reg #: 9613419
·
FEI: 3000168341
·
Expires 2026
Products
3
Proprietary Names
15
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- HMC Premedical S.p.A.
- Registration Number
- 9613419
- FEI Number
- 3000168341
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Bosco 1/3
- City
- MIRANDOLA Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K031128
Owner / Operator
- Firm Name
- HMC Group
- Operator Number
- 9041724
- Address
- Via Bosco 1/3, --
- City
- Mirandola
- State
- Modena
- Postal Code
- 41037
- Country
- IT
US Agent
- Business Name
- ISOPLAN USA
- Contact Name
- Lorenzo Da Madice
- Address
- 3408 Rexford Cir
- City
- Ormond Beach
- State
- FL
- ZIP
- 32174
- Country
- US
- [email protected]
- Phone
- 386 8680618
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2018-05-03 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2006-05-05 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2025-12-22 |
Proprietary Names
BA02BL ENFit Bottle Adapter 15mm-16.5mm - Bulk
BA03L ENFit Bottle Adapter 18mm-19.5mm
BA02L ENFit Bottle Adapter 15mm-16.5mm
BA07L ENFit Bottle Adapter 10.5mm-11mm
BA06L ENFit Bottle Adapter 20mm-21.5mm
BA01BL ENFit Stepped Bottle Adapter - Bulk
BA03BL ENFit Bottle Adapter 18mm-19.5mm - Bulk
BA04L ENFit Bottle Adapter 25.5mm-27mm
BA08L ENFit Bottle Adapter 16.5mm-18mm
BA04BL ENFit Bottle Adapter 25.5mm-27mm - Bulk
BA01L ENFit Stepped Bottle Adapter
BA05L ENFit Bottle Adapter 18.5mm-20.5mm
B-SMART PRESSURE MANOMETER
B-SMART
Enteral Drainage System, Enteral Medicine straw
Establishment Types
Manufacture Medical Device