FDA Registration
Active
🇸🇪 Sweden
NATURALCYCLES NORDIC AB
Reg #: 3014848805
·
FEI: 3014848805
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
5
Classifications
6
Registration Details
- Registration Name
- NATURALCYCLES NORDIC AB
- Registration Number
- 3014848805
- FEI Number
- 3014848805
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- St Eriksgatan 63b
- City
- Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K043443
Owner / Operator
- Firm Name
- Natural Cycles Nordic AB
- Operator Number
- 10058341
- Address
- St Eriksgatan 63b
- City
- Stockholm
- State
- SE-AB
- Postal Code
- 11234
- Country
- SE
- Correspondent
- Raoul Scherwitzl
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Fertility Diagnostic, Proceptive | LHD | Class U | Unknown | No | 2022-11-30 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2022-03-11 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2022-03-11 |
| Device, Fertility Diagnostic, Contraceptive, Software Application | PYT | Class 2 | Obstetrics/Gynecology | No | 2023-09-15 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2021-10-08 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2020-01-08 |
Proprietary Names
Cycle Tracking
Natural Cycles Pregnancy Test
Natural Cycles
Clearblue & Natural Cycles° Birth Control Kit Starter Pack
Clearblue & Natural Cycles° Birth Control Ovulation Test Refill Pack
Natural Cycles Ovulation Test
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device