1. the US FDA also determined it was a Class II device. Class III devices require a PMA instead of a 510(k). The CFDA is reported by many to be more difficult than the US FDA so let's not count those CFDA chickens before they are hatched.
2. Despite what Gene-O says, the China Launch is WAY BEHIND SCHEDULE, which a little DD will reveal. Even reading yesterday's posts from two of the board's more learned and stable contributors reveals this truth (12887, 12888).
3. Another cause of death of women in China: parents killing babies because they are female. Sorry but this is STILL HAPPENING.
4. "CHINA Approval is 99% after changes of Clssication [sic] from Class 3 TO 2!!!!!!!!!!" is complete and utter fantasy.
5. The stop sign won't get removed until Gene-O files that pesky 10-K. and when he does we are going to know whether the claims of "SALES FLOODING IN" and "WOMEN EVERYWHERE ARE USING THE DEVICE" are true and justify the shouting.
6. Everett Jolly pumps stocks that he bought and subsequently went south.
6b. ALL major exchanges can only report what is filed. They will ALL update when Gene-O files that pesky 10-K.
7. Crypterium is for suckers.
8. "China Chose Contractor" is Shandong Yaohua Medical Instrument Corp. Here is their website: https://yaohuamedical.en.ecplaza.net/
"Our main products are vacuum blood tube, urine analyzer, urine strips, PET tube,cervical scanner, pen-type needle, needle holder, butterfly needle, pharmaceutical package. "
They make some pretty simple stuff -- test tubes and needles -- are they capable of manufacturing the Luviva device? And don't you love the way they threw "cervical scanner" into their blurb above? News flash: It's not one of your "main products" yet, Shandy, because you can't sell it yet.
As for the YH-1520A Urine Analyzer: You can buy it on Alibaba (where you can also buy counterfeit bootleg EVERYTHING, from Coach purses to Nike shoes to Gibson guitars): https://www.alibaba.com/product-detail/YH-1520A-URINE-ANALYZER_60683074917.html
They claim to have Annual revenue "more than US$1,000,000." That isn't much revenue, sorry. That's why they had so much trouble paying the second installment of that initial $1M USD payment. This is a small company... Believe in CFDA approval when you see it and not before.
And that, my friend, is called "Getting Serious."