FDA Registration
Active
🇸🇪 Sweden
NEKO HEALTH AB
Reg #: 3042165671
·
FEI: 3042165671
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- NEKO HEALTH AB
- Registration Number
- 3042165671
- FEI Number
- 3042165671
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Svardvagen 19
- City
- Danderyd Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K254129
Owner / Operator
- Firm Name
- Neko Health AB
- Operator Number
- 10094483
- Address
- Svardvagen 19
- City
- Danderyd
- State
- Stockholm
- Postal Code
- 182 33
- Country
- SE
- Correspondent
- Per Sundstrom
US Agent
- Business Name
- Neko Health Inc
- Contact Name
- Doug Lane
- Address
- 148 Lafayette St
- City
- New York
- State
- NY
- ZIP
- 10013
- Country
- US
- [email protected]
- Phone
- 323 3957237
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2026-05-28 |
| Holder, Camera, Surgical | FXR | Class 1 | General, Plastic Surgery | No | 2026-06-18 |
| Camera, Still, Surgical | FTT | Class 1 | General, Plastic Surgery | No | 2026-05-28 |
| System, Telethermographic (Adjunctive Use) | LHQ | Class 1 | Obstetrics/Gynecology | No | 2026-05-28 |
| Light Based Imaging | PSN | Class 2 | General, Plastic Surgery | No | 2025-12-05 |
Proprietary Names
Spectrum-2
Positioner-1
Derma-2
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility