Surgical device manufacturer since 1994.
AeroMed Surgical is the international brand of Beijing HangTian KaDi Technology R&D Institute. We develop and manufacture professional surgical devices across Cardiac Surgery, General & MIS Surgery, and Women’s Health, with product-specific documentation, evaluation support, and international distributor cooperation.
Brand and legal-manufacturer relationship
AeroMed Surgical is the international brand.
Beijing HangTian KaDi Technology R&D Institute is the legal manufacturer and certificate holder where stated in the applicable product documentation.
Customers should use the exact legal-manufacturer, model, certificate, and label information contained in the current product-specific document package.
What should international buyers know first?
AeroMed combines an established manufacturing base with clearer international product communication, model selection, documentation, evaluation, and partnership support.
International brand of a Chinese surgical device manufacturer established in 1994.
Cardiac Surgery, General & MIS Surgery, and Women’s Health product families.
Manufacturing history, product depth, ISO 13485 quality system, hospital-supply records, and model-specific documentation.
Distribution, hospital evaluation, registration support, OEM/private label, packaging, and product-development discussion.
Manufacturing and engineering capacity at a glance.
These figures describe the manufacturer behind AeroMed Surgical and should be distinguished from product-specific regulatory claims.
From clinical need to controlled manufacturing.
The manufacturer combines clinical-demand translation, product engineering, precision manufacturing, quality control, and documentation management.
Headquarters, engineering, and manufacturing
Approximately 4,000 m² of company-owned office and production space, including a 625 m² Class 10,000 cleanroom.
Additional manufacturing capacity
Approximately 3,100 m² operated through Hunan Tianyi Fangjian Biotechnology Co., Ltd., supporting manufacturing and scale-up requirements.
System-level product thinking
The company applies systems-engineering, tolerance control, reliability, and precision-manufacturing discipline to surgical-device development and production.
ISO 13485:2016
Certificate Q5 090358 0007 Rev. 04, valid from 10 February 2026 to 11 November 2027. Product regulatory status remains model- and market-specific.
Three surgical product lines.
Single-port access is part of the General & MIS portfolio rather than a separate fourth product line.
OPCAB, MICS, and cardiac access support
Heart Stabilizer System, reusable frame, stabilizer foot family, sternal retractor, blower/mister, and disposable suture holder.
- • System and component selection
- • Model-specific CE/FDA pathway review
Access, protection, retrieval, exposure, and closure
Single-port access, wound retractors, specimen retrieval bags, ring retractors, fascial closure, cyst suction needle, and articulating instruments.
- • Standard and procedure-specific access
- • New product and OEM opportunities
Gynecology and obstetrics
Uterine Manipulator, reusable and single-use Uterine Cups, and Obstetric Suction Cup configurations.
- • Product-specific regulatory status
- • Configuration-led selection
Established product families, presented with a conservative evidence boundary.
AeroMed is a newer international brand, while selected product families are supported by long-term manufacturing and hospital-supply histories in China.
2,000+ hospitals supplied
Historical manufacturer records include more than 300 Class III Grade A hospitals.
1,500+ hospitals with repeat records
Repeat-supply history is an additional trust signal for qualified distributor evaluation.
Product-family document packages
Available materials may include model matrices, IFUs, labels, verification summaries, samples, training resources, product images, and selected clinical-use references.
History does not replace current documentation
Hospital-supply history is not a clinical outcome claim and does not replace the current certificate, IFU, label, or target-market model scope.
How AeroMed supports distributors, hospitals, and OEM partners.
The goal is to move from a broad inquiry to a clear product, document, evaluation, and market-development plan.
Define the market need
Country, department, procedure, product family, target hospitals, and intended commercial model.
Confirm product scope
Exact models, dimensions, accessories, packaging, samples, and product-use boundary.
Review documents
Certificates, IFUs, labels, model matrices, ISO documentation, registration files, and quotations.
Plan evaluation or launch
Samples, product training, hospital evaluation, registration support, distribution, or OEM/private label development.
Company facts can be shared broadly. Regulatory claims cannot.
Every CE, FDA, SFDA, NMPA, sterilization, shelf-life, indication, and market-availability statement must be checked against the exact product, model, certificate, IFU, label, and target market.
Public wording rule: FDA registration, listing, or 510(k) status does not mean “FDA approved.” The About page establishes manufacturer identity and capability; product pages and controlled documents establish product-specific regulatory status.