FDA Registration
Active
🇨🇭 Switzerland
OneTouch SureSoft Lancet
Reg #: 3008382007
·
FEI: 3008382007
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LIFESCAN EUROPE GMBH
- Registration Number
- 3008382007
- FEI Number
- 3008382007
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Dammstrasse 19
- City
- CH Zug
- Country
- CH
Owner / Operator
- Firm Name
- LifeScan Europe, GmbH
- Operator Number
- 10032336
- Address
- Beechwood Park North
- City
- Inverness
- State
- Highland
- Postal Code
- IV2 3ED
- Country
- GB
- Correspondent
- Jenny Mackenzie
US Agent
- Business Name
- LIFESCAN INC
- Contact Name
- Janice Thompson
- Address
- 20 Valley Stream Parkway
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 484 8167226 ext. 10304
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2011-04-12 |
Proprietary Names
OneTouch SureSoft Lancet
OneTouch UltraSoft Lancing Device and Lancets
OneTouch Delica Lancing Device and Lancets
OneTouch Lancing Device
OneTouch FinePoint Lancets
OneTouch Delica Safety Lancing Device and Lancets
OneTouch Delica Plus Lancing Device and Lancets
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility