Women’s Health Devices
Start with the clinical workflow, then select the product configuration and request the exact regulatory package for your market. AeroMed separates uterine manipulation, colpotomy delineation, pre-induction cervical ripening, assisted vaginal delivery, and transvaginal access so customers can evaluate each product family without mixing indications or regulatory status.
Choose the product family by workflow.
The page is organized around the customer’s first question: what clinical or procurement need are you evaluating?
Four Women’s Health product families.
Explore four dedicated product pages, including HK-CDB-80/80(A) and (B). Regulatory status varies by model and market.
GYNECOLOGY
Uterine Manipulator
WQ fixed-angulation and ZQ adjustable-angulation configurations with braided steel-cable internal architecture.
TLH COMPANION
Uterine Cup
Black ceramic reusable and blue PPS single-use companion cups for use with a compatible uterine manipulator.
OBSTETRICS
Cervical Ripening Balloon
Mechanical cervical ripening before labor induction, subject to the current IFU. Distributor inquiries welcome.
OBSTETRICS
Obstetric Suction Cup
Sterile single-use vacuum-assisted delivery system with four configuration pathways for product selection.
The HK-FDDC-4TNOS vNOTES Single-Port Platform is a CE-marked, single-use sterile four-channel access solution. It remains under the General & MIS / Single-Port website structure.
Braided steel-cable transmission inside WQ and ZQ.
A sectioned engineering sample makes the internal cable paths visible while the product page retains the correct selection boundary between WQ and ZQ.
See the transmission architecture
Both HK-WQ-II and HK-ZQ-II use internal braided steel-cable routing. HK-WQ-II provides fixed distal angulation with adjustable insertion length. HK-ZQ-II provides handle-controlled distal angulation with model-specific working lengths.
Comparative force and clinical performance statements require defined test methods and approved data.
Explore the Uterine ManipulatorUnderstand the relationship before comparing models.
The portfolio is easiest to evaluate as four distinct workflow needs rather than one combined regulatory bundle.
Select fixed or adjustable angulation, then confirm working length, shaft diameter, labeling, and FDA model scope.
- • HK-WQ-II
- • HK-ZQ-II item-number family
Choose reusable ceramic or single-use PPS, then select the 30, 35, 40, or 46 mm diameter.
- • UC-P reusable
- • UC-F single-use
Compare the standard, traction-indicator, fluid-management, and extended-stem configurations.
- • HK-TTQ A / B / C / D
- • CE and SFDA documents
Compare HK-CDB-80/80(A) without stylet and (B) with removable stylet and review their model-specific documentation; CE review is ongoing.
- • HK-CDB-80/80(A)
- • Target-market status to be confirmed
Product-specific models and regulatory status.
Customers should request certificates, IFUs, declarations, labels, and technical files by product family and target market.
| Product Family | Models / SKUs | Customer Selection | Public Regulatory Position |
|---|---|---|---|
| Uterine Manipulator | HK-WQ-II · HK-ZQ-II item-number family | Angulation · insertion / working length · shaft diameter | FDA 510(k) K172846 · Not CE-marked |
| Uterine Cup | UC-P / UC-F · 30 / 35 / 40 / 46 mm | Reusable ceramic or single-use PPS · diameter | Covered under K172846 as companion component · Not CE-marked |
| Cervical Ripening Balloon | HK-CDB-80/80(A) | Mechanical cervical ripening before induction of labor; check current IFU | CE review ongoing; no current CE-marked claim |
| Obstetric Suction Cup | HK-TTQ-A / B / C / D | Pump and cup configuration · traction indicator · fluid management · stem/cup design | CE-marked · SFDA registered in Saudi Arabia |
| Related vNOTES Platform | HK-FDDC-4TNOS | Inflatable / balloon anchoring or double-ring support · four channels | CE-marked · Single-use sterile |
Do not apply one regulatory status to the entire portfolio.
Regulatory status varies by product family, model, and country. The website provides a commercial overview, not a substitute for approved labeling.
Confirm the priority product, exact model, target country, evaluation quantity, and required document set before quotation or registration support.
Request the product-specific document package.
Catalogs, model matrices, IFUs, labels, certificates, sterilization information, shelf-life data, product images, and quotations are provided according to the selected product and market.