FDA Registration
Active
🇮🇹 Italy
Delta Med SpA
Reg #: 3006846316
·
FEI: 3006846316
·
Expires 2026
Products
4
Proprietary Names
14
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Delta Med SpA
- Registration Number
- 3006846316
- FEI Number
- 3006846316
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- via Guido Rossa 20
- City
- viadana Mantova
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K140175
Owner / Operator
- Firm Name
- Delta Med SpA
- Operator Number
- 10023539
- Address
- Via Guido Rossa 20
- City
- Viadana
- State
- Mantova
- Postal Code
- 46019
- Country
- IT
US Agent
- Business Name
- Donawa Lifescience INC
- Contact Name
- Stephen Lieberman
- Address
- 4545 N Ocean Blvd Apt 11a
- City
- Boca Raton
- State
- FL
- ZIP
- 33431
- Country
- US
- [email protected]
- Phone
- 561 3020777 ext. 1
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2014-11-28 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2013-02-15 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2014-04-04 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2007-11-30 |
Proprietary Names
Delta Fly F20u Micro Bore Winged Safety Needles
Delta Fly Safe 23G 30cm
Delta Fly Micro Bore Winged Safety Needles
Delta Fly Micro Bore Winged Safety Needle 21G 35cm
Delta Fly Safe 21G 30cm
Delta Fly Safe 25G 30cm
Neo Delta Self Safe T 26G 19mm
Neo Delta Self Safe 1 26G 19mm
MERICATH SAFETY WINGED 24G 19MM
Neo delta self safe 1
Neo delta self safe T
Arrow International, Inc 312 Commerce Place Asheboro, NC 27203
Deltaven Closed I.V. Catheter Systems
SURGICAL DRAPE KIT
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device