Eu Ivdd
Eu Ivd Self Testing
On The Market
🇹🇼 Taiwan
PHRONESIA Smart Ovulation Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04719872951889
- Basic UDI-DI Code
- B-04719872951889
- Reference
- 1889
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- iXensor Co., Ltd.
Additional Description
PHRONESIA is an ovulation self-test to detect luteinizing hormone (LH) levels in the urine for predicting the most fertile window. The PHRONESIA ovulation test is to be read by naked eyes or can also be interpreted using the PHRONESIA App and the Smart Scanner for improving the tracking of fertile days while recording fertility status and symptoms.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160304 | LH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 614409 | BSI Group The Netherlands B.V. | Expired |
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