How is the AeroMed Surgical product portfolio organized?

The site lists sixteen dedicated product pages including an HK-CDB-80/80(A)/(B) product page across Cardiac Surgery, General and MIS, and Women’s Health. OEM and private-label manufacturing has a separate page.

Are all AeroMed Surgical products CE marked or FDA cleared?

No. Regulatory status varies by product, model, certificate scope, intended use, and target market. The portfolio page shows product-specific public wording and directs distributors to request the current regulatory matrix.

Which AeroMed Surgical products have FDA documentation?

The Heart Stabilizer family is presented as FDA listed and 510(k)-exempt. FDA 510(k) K172789 documentation is associated with applicable Specimen Retrieval Bag configurations. FDA 510(k) K172846 documentation is associated with the Uterine Manipulator and Uterine Cup product scope. Exact model coverage should be confirmed before public or commercial use.

Where can partners discuss OEM and private-label manufacturing?

The dedicated OEM page explains manufacturing pathways and currently presents Cyst Suction Needle and Single-use Cervical Biopsy Forceps as project discussions. Articulating laparoscopic instruments remain in the General and MIS product portfolio.

How can a distributor request product and regulatory documents?

Distributors can request a model matrix, current regulatory-document list, catalog pages, IFU and labeling information, packaging details, sample discussion, training support, and quotation by contacting AeroMed Surgical with the target country and product family.

Surgical Device Product Portfolio

Find the right product family—and its actual regulatory status.

Explore AeroMed Surgical product families across Cardiac Surgery, General & MIS, and Women's Health. OEM manufacturing has a separate page; product-specific regulatory status is shown here.

Availability, intended use, certificate scope, and market authorization must be confirmed by product, model, and target country.

Explore Established Products View Regulatory Status

Quick Answer

What can a distributor understand from this page?

The page presents product families by clinical domain and links OEM manufacturing to a dedicated page. Regulatory status is specific to each product and market.

Portfolio

What does AeroMed offer?

Sixteen dedicated product pages, including the HK-CDB-80/80(A)/(B) product page across three domains. OEM projects are presented separately.

Regulatory

Are all products CE or FDA?

No. CE, FDA, SFDA Saudi, and NMPA status varies by product, model, documentation scope, and target market.

Subfamilies

Where are the subpages?

Single-Port subfamilies and Hang T Safe are shown under their parent product families rather than as unrelated product categories.

Evaluation

What can partners request?

Model matrices, current document lists, catalogs, IFU and labeling information, samples, training, and quotation support.

Choose a Surgical Domain

Start with the clinical and product area you serve.

6 Established Product Families

Cardiac Surgery

OPCAB stabilization, positioning, exposure, suture management, and anastomotic field support.

Heart Stabilizer · HK-GDQ · Stabilizer Foot · Sternal Retractor · Blower / Mister · Suture Holder

5 Established Product Families

General & MIS

Access, wound protection, specimen retrieval, surgical exposure, and closure.

Single-Port · Wound Retractor · Specimen Bag · Ring Retractor · Fascial Closure

4 Product Pages · 1 in CE Review

Women's Health

Gynecology and obstetric product families with different FDA, CE, and SFDA Saudi pathways.

Uterine Manipulator · Uterine Cup · Cervical Ripening Balloon · Obstetric Suction Cup

How to Read Regulatory Status

One badge does not mean the same thing for every device.

Public wording is kept specific so that an FDA listing, an FDA 510(k), a CE certificate, an SFDA Saudi registration, and an NMPA registration are not treated as interchangeable.

CE documentation

Applies according to the current certificate, device classification, product family, and model scope.

FDA

FDA pathway

May mean FDA 510(k) documentation or FDA listing / 510(k)-exempt status, depending on the product.

SFDA Saudi

Selected registered models

Applies only to the exact product and model covered by the current Saudi registration.

NMPA China

China registration

China registration does not by itself indicate CE marking or authorization in another international market.

Established Product Portfolio

Cardiac Surgery

Six product families for OPCAB stabilization, positioning, exposure, and procedural support.

View Cardiac Surgery Suite →

OPCAB Stabilization

Heart Stabilizer System

Single-use beating-heart stabilization system with standoff and stabilizer-foot configurations for documented OPCAB workflows.

Product Family	Domain	Public Regulatory Wording	Important Boundary	Product Page
Heart Stabilizer System	Cardiac	CE Class III · FDA Listed / 510(k)-Exempt	Separate the Class III system from reusable-frame MDR status.	View
Reusable Stabilizer Frame	Cardiac	CE MDR Class I · Reusable	Do not present it as a separate FDA-cleared device.	View
Stabilizer Foot Family	Cardiac	CE · Heart Stabilizer component scope	Confirm foot and system combinations by model.	View
Sternal Retractor	Cardiac	CE MDR Class I · Reusable	Reprocessing and configuration remain IFU-led.	View
Surgical Blower / Mister	Cardiac	CE documentation · Model scope	Confirm current models and functional wording.	View
Disposable Suture Holder	Cardiac	CE documentation · Model scope	Separate suture management from mounting-interface use.	View
Articulating Laparoscopic Instruments	General & MIS	NMPA China · CE review ongoing	CE marking has not yet been granted; confirm target-market status.	View
Single-Port Access System	General & MIS	CE documentation · Configuration and model scope	Child configurations do not automatically share identical claims.	View
Wound Retractor & Protector	General & MIS	CE documentation · Model scope	Confirm fixed, variable, Q, Q1, and specialty models.	View
Specimen Retrieval Bag	General & MIS	CE documentation · FDA 510(k) K172789 where applicable	Do not extend the FDA claim to every open or closed configuration.	View
Ring Retractor System	General & MIS	CE documentation · Model scope	Confirm ring, hook, and specialty scope.	View
Fascial Closure Device	General & MIS	CE documentation · SFDA Saudi selected models	Confirm gauge and Saudi registration scope.	View
Uterine Manipulator	Women's Health	FDA 510(k) K172846 · No CE claim	Confirm current marketed model and FDA scope.	View
Uterine Cup	Women's Health	FDA 510(k) K172846 · No CE claim	Confirm reusable / single-use type, PPS material, and 46 mm size.	View
Cervical Ripening Balloon	Women's Health	HK-CDB-80/80(A) / (B) · B with stylet in stock · CE review ongoing	No current CE-marked claim; confirm target-market status before supply.	View
Obstetric Suction Cup	Women's Health	CE documentation · SFDA Saudi selected models	Confirm A / B / C / D model differences and registration scope.	View

Find the right product family—and its actual regulatory status.

What can a distributor understand from this page?

What does AeroMed offer?

Are all products CE or FDA?

Where are the subpages?

What can partners request?

Start with the clinical and product area you serve.

Cardiac Surgery

General & MIS

Women's Health

One badge does not mean the same thing for every device.

CE documentation

FDA pathway

Selected registered models

China registration

Cardiac Surgery

Heart Stabilizer System

Reusable Stabilizer Frame

Stabilizer Foot Family

Sternal Retractor

Surgical Blower / Mister

Disposable Suture Holder

General & MIS

Articulating Laparoscopic Instruments

Single-Port Access System

Wound Retractor & Protector

Specimen Retrieval Bag

Ring Retractor System

Fascial Closure Device

Women's Health

Uterine Manipulator

Uterine Cup

Cervical Ripening Balloon

Obstetric Suction Cup

Public wording for initial portfolio evaluation.

Explore OEM manufacturing separately.

Request a product and regulatory matrix.