OEM and Private Label Manufacturing

Medical device OEM manufacturing with product-specific regulatory planning.

AeroMed Surgical, the international brand of Beijing HangTian KaDi Technology R&D Institute, discusses private label, product configuration, packaging and manufacturing projects with qualified partners. Begin with the intended device, target country and responsibilities; the technical and regulatory scope is agreed project by project.

Start with the project brief

Product: intended use, key specification and proposed label.

Market: country, planned regulatory route and partner responsibilities.

Manufacturing: configuration, packaging, forecast and quality requirements.

Documentation: current files are reviewed against the proposed scope.

OEM Cooperation

Define the manufacturing and regulatory scope together.

Projects may involve an existing configuration with private labeling, changes to packaging or specifications, or broader contract manufacturing. Feasibility, intellectual property, quality agreements, validation and registration roles depend on the project and target market.

Brand

Private label

Discuss labeling and packaging only after the device and market scope are identified.

Device

Configuration

Review drawings, materials, intended use and changes requiring verification.

Quality

Manufacturing

Align production, inspection, traceability and the responsibilities in a quality agreement.

Market

Regulatory plan

Confirm which documents and authorizations apply to the proposed finished device.

Current Project Discussions

Two devices for OEM evaluation.

These are project discussions, not a list of current CE-marked export products. Exact specifications, production scope and country-specific permissions require written review.

OEM Project · General and MIS

Cyst Suction Needle

Discuss device configuration and manufacturing scope for professional cyst aspiration applications against the current controlled technical documents. Historical CE materials do not establish present MDR continuation or EU market authorization.

  • • Confirm the model and intended use
  • • Review quality and labeling responsibilities
  • • Assess regulatory pathway for the target country
Discuss this OEM project →
OEM Project · Gynecology

Single-use Cervical Biopsy Forceps

Discuss a professional cervical tissue sampling device. An older HTKD brochure describes historical jaw and length options; current specifications, production availability, sterilization and regulatory scope must be verified before quotation.

  • • Confirm jaw geometry and intended use
  • • Agree packaging and labeling scope
  • • Verify current target-market authorization
Discuss this OEM project →
Project Process

From brief to documented scope.

01

Describe the need

Share your organization, target country, device and intended project scope.

02

Review feasibility

Discuss technical requirements, current manufacturing capability and forecast.

03

Align responsibilities

Agree verification, labeling, quality and regulatory roles before commitments.

04

Plan evaluation

Define approved documentation, samples where permitted and commercial next steps.

OEM FAQ

Questions partners ask first.

What information should an OEM partner provide?
Please provide your company, target country, product concept or model, intended use, expected volume, desired labeling and the proposed registration role.
Are the two OEM projects currently CE-marked?
No present CE-marked claim is made for either OEM project on this page. Current documents and target-market authorization must be verified before a commercial claim or supply commitment.
Can specifications and packaging be customized?
Potential changes are discussed after technical, quality, regulatory and commercial feasibility review. The agreed project scope determines validation and documentation responsibilities.
Is a confidentiality agreement used?
Confidential technical and commercial material is shared progressively under an appropriate agreement after the initial project review.
OEM Inquiry

Tell us what you want to make and where it will be marketed.

Share the device, target country, intended use, desired configuration and your project stage. We will identify the documents and responsibilities needed for a specific discussion.