FDA Registration
Active
🇸🇪 Sweden
Linxens Sweden AB
Reg #: 3012606445
·
FEI: 3012606445
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Linxens Sweden AB
- Registration Number
- 3012606445
- FEI Number
- 3012606445
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Brandsvigsgatan 11A
- City
- Angelholm Skane
- Country
- SE
Owner / Operator
- Firm Name
- Linxens Sweden AB
- Operator Number
- 10051513
- Address
- Brandsvigsgatan 11A
- City
- Angelholm
- State
- Skane
- Postal Code
- 26273
- Country
- SE
- Correspondent
- Carina Backstrom Hassel
US Agent
- Business Name
- QRx Partners
- Contact Name
- Mark Swanson
- Address
- 16904 77th Street SE
- City
- Becker
- State
- MN
- ZIP
- 55308
- Country
- US
- [email protected]
- Phone
- 833 7797278
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2025-04-15 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2025-04-15 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2023-12-12 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2016-03-29 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-02-19 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2019-02-18 |
Proprietary Names
BodyGuardian Mini Bridge SB2002
SP2003 BodyGuardian Mini Easy Slide Strip
Universal Patch
SP2003 BodyGuardian Mini Slide Strip
SP2004 BodyGuardian Mini Short Slide Strip
SP1003 Acrylic Snapstrip
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)