Women’s health | Two More Mednovo Products received NMPA Approval
2024-02-23 17:32
Recently, Wuxi Heyun Medical Technology Co., Ltd., a subsidiary of Mednovo Group, independently developed Breast Localization Wire and Introducer Needle for single us (certificate no.: 苏械注准 20242020234) and Disposable Embryo Transfer Catheter (certificate no.: 苏械注准 20242180200), and both obtained Medical Device Registration Certificatesissued by the Jiangsu Medical Products Administration.
Up to now, Mednovo has obtained a total of 19 medical device registration certificates.
1. Breast Localization Wire and Introducer Needle for single use
01. Product Introduction
The product consists of a localizationwire, anintroducer needle, and a marker clip. The localizationwire has localization marker and deployment marker, and the head is equipped with a barb, used for localization of breast biopsy during surgery.
02. Product features
The localizationwire has a barb tip and is bend-resistant, so as to ensure effective anchoring of the lesion tissue and minimize its migration.
The location markeriscompact twists shaped and shows perfectly under X-ray/ultrasound, physicians can easily locate the lesion tissue during the surgical process.
The deployment marker is touchable twists shape, physicians can easily know whether the wire is released inside the introducer needle.
The introducer needle adopts special processing technology, which gives better pushability to the insidelocalization wire and reduce operation difficulty; its surface is marked with a scale where 5cm is highlighted, easy to determine the pushing distance. The introducer needle has imaging properties under ultrasound and X-ray, thus easy to observe.
The raised dots on the handle point out the cutting edge of the needle tip, easy to operate; different colors are used to indicate different diameters of needles, 20G-yellow, 19G-transparent, and 18G-pink.
2. Disposable Embryo Transfer Catheter
01. Product Introduction
The product is to be used together with a syringe to transfer embryos or fertilized eggs that have undergone in vitro fertilization (IVF) to the vagina.
Two types:
The ETA type disposable embryo transfer catheter consists of a guide catheter, a transfer catheter, and stainless steel inner core;
The ETN type disposable embryo transfer catheter consists of a guide catheter and a transfer catheter.
02. Product features
The olive shaped design of the catheter tip effectively prevents cervical mucus from entering, reduces damage to cervix and endometrium caused by the catheter edge during surgery, and gives comfortable touch.
The anterior segment of guide catheter is pre bent at an oblique angle, which conforms to physiological shape and gives easier passage through the cervix.
The movable depth limiter is beneficial for grasping the guide catheter’s position in the uterine cavity.
The front end of the transplanted catheter is tapered and blunt, effectively reducing damages to endometrium during surgery and minimizing stimulation to it.
The outeris made of stainless-steel material, and the tip is chamfered for easy entry, reducing assembly blockage.
The scale mark at the end indicates the length of the transfer catheter that goes beyond the guide catheter, directly reflecting the depth of the transfer catheter entering uterine cavity, thus accurately guiding embryo transfer to ideal location.
The handle marks match the bending direction of catheter, easier for doctors to make adjustment.
These two new medical device registration certificates not only enrich Mednovo's product line in the field of women's health, providing more choices for clinical use, but also injects new impetus into Mednovo's development.