CDSCO UID MFG/MD/2022/000289_383e75bc490ebb888fb2bf6d25a22ef7_53fe599115346815b1dc848c4b2ae604

BULB EMBRYO TRANSFER CATHETER

NILAUM HEALTHCARE·Device Class Class B·India CDSCO

Registration details

UID: MFG/MD/2022/000289_383e75bc490ebb888fb2bf6d25a22ef7_53fe599115346815b1dc848c4b2ae604
Device class: Class B
License holder: NILAUM HEALTHCARE
Approving authority: Kokan Division
Product information: Bulb Embryo Transfer (NA) Catheter is the final and most crucial step in IVF. About 80% of patients undergoing IVF reach the embryo transfer stage, but only a small proportion of them achieve pregnancy. The pregnancy rate after embryo transfer is dependent upon multiple factors including embryo quality, endometrial receptivity and the technique of the embryo transfer itself therefore decided to systematically review the evidence provided in the literature so that we may evaluate a single variable in relation to a successful transfer, the firmness of the embryo transfer catheter. Transferring embryos into the uterine cavity during in vitro fertilization procedures. The subject device includes the TransemStylet, which is intended to assist insertion of the catheters by maintaining rigidity of the device. While the use of a Stylet is not included in the predicate device Indications for Use statement, the inclusion of the Stylet does not represent a new intended use for the device. The predicate device indication includes a trial transfer catheter, used to determine whether the cervix is passable. The subject device does not contain a trial catheter; However, the lack of a trial catheter does not change the intended use of the subject device