Basic Information
- Primary DI
- 09317039000460
- Basic UDI-DI Code
- B-09317039000460
- Reference
- MB 00.00.00
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- OPTIX DOO BEOGRAD-ZEMUN
Additional Description
Maybe Baby is a precision instrument (optical system: magnification 52±2 times) used to examine a crystallized salts in the dry saliva sample, which under illumination from a LED light source, can be seen as “fern leaves”. It is an individual medical diagnostic instrument, for everyday use, by means of which, on the basis of saliva, it is possible to detect fertile and infertile days during the menstrual cycle of a woman. Due to the increased contents of estrogen hormones during the fertile days, the quantity of salts in saliva rises. By means of the optical system magnifying 52 times, crystallized salts in the dry saliva sample can be seen as “fern leaves”.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160399 | FERTILITY/PREGNANCY RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | D1415200003 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).