FDA Registration
Active
🇮🇹 Italy
ARTSANA PISTON AND INSULIN SYRINGES
Reg #: 3014165712
·
FEI: 3014165712
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- PIKDARE S.p.A.
- Registration Number
- 3014165712
- FEI Number
- 3014165712
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Saldarini Catelli 10
- City
- Casnate con Bernate Como
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K052667
Owner / Operator
- Firm Name
- PIKDARE S.P.A.
- Operator Number
- 10056365
- Address
- Via Saldarini Catelli 10
- City
- Casnate con Bernate
- State
- Como
- Postal Code
- 22070
- Country
- IT
- Correspondent
- Roberta Zanoni
US Agent
- Business Name
- HTL-Strefa, Inc.
- Contact Name
- Sylvie Verdon
- Address
- 113 Towne Lake Pkwy
- City
- Woodstock
- State
- GA
- ZIP
- 30188
- Country
- US
- [email protected]
- Phone
- 770 5280410
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2017-12-01 |
Proprietary Names
ARTSANA PISTON AND INSULIN SYRINGES
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device