FDA Registration
Active
🇨🇭 Switzerland
Electric Pen Drive System
Reg #: 3010363503
·
FEI: 3010363503
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- FRUEH VERPACKUNGSTECHNIK AG
- Registration Number
- 3010363503
- FEI Number
- 3010363503
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Allmendstrasse 47
- City
- Fehraltorf Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K043310
Owner / Operator
- Firm Name
- Frueh Verpackungstechnik AG
- Operator Number
- 10043460
- Address
- Allmendstrasse 47
- City
- Fehraltorf
- State
- Zurich
- Postal Code
- 8320
- Country
- CH
- Correspondent
- Regina Bruggisser
US Agent
- Business Name
- Fruh Packaging Inc.
- Contact Name
- Jeffrey Zoleta
- Address
- 240 Sierra Drive
- City
- Exton
- State
- PA
- ZIP
- 19341
- Country
- US
- [email protected]
- Phone
- 267 4993244
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2017-03-21 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2017-03-21 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2017-03-21 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2017-03-21 |
Proprietary Names
Electric Pen Drive System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)