Contract Manufacturer for Medical Technology: Development, Injection Molding, Cleanroom Assembly and Packaging from a Single Source
KH Medical GmbH
Helmbrechts (DE) · Sparneck (DE) · Chodov (CZ) · Suzhou (CN) · Querétaro (MX)New on Amplifa
About KH Medical
KH Medical GmbH is a contract manufacturer (CDMO/CMO) for medical technology headquartered in Helmbrechts, Upper Franconia, and part of the family-owned Kunststoff Helmbrechts Group (KH Group). The company realizes complex medical technology projects from engineering through toolmaking and injection molding to assembly in cleanrooms of classes 7 and 8 (ISO 14644-1), end-of-line testing, packaging including in-mold labeling and logistics. It produces plastic components, assemblies and multi-material parts, including products made of highly transparent glass, metal and plastic, such as single-use endoscopes, autoclavable eye funnels and housings for blood glucose meters and hearing aids. In addition to the medical sector, KH supplies the automotive and industrial industries as a group network, with medical processes run separately from industrial ones. The group operates five production sites on three continents in Germany, the Czech Republic, China and Mexico. Quality management is certified to EN ISO 13485 and IATF/TS 16949.
- Site
- Helmbrechts
- Processes
- Injection Molding, Toolmaking (Tool shop), Development / Engineering, Surface Technology, Cleanroom Assembly (manual and semi-automated, ISO 14644-1 Class 7/8), End-of-Line Testing / Inspection, Packaging, Logistics / Global Procurement
- Materials
- Plastic, Glass (highly transparent), Metal, Highly transparent glass, In-Mold Labeling, Injection Molding (medtech-optimized), Cleanroom Manufacturing ISO 14644-1 Class 7/8, End-of-Line Testing
- Certificates
- EN ISO 13485, IATF / TS 16949, ISO 14644-1 Class 7/8 (Cleanroom)
- Founded
- 1958 (KH-G
- Employees
- KH Group: 1150–1500
- Industries
- Medical Technology, Contract Manufacturing, Automotive, Industrial, Biomonitoring, Medical Technology/Medical Devices
- 01
Development/Engineering
- 02
Toolmaking/Tool Design
- 03
Injection Molding
- 04
Surface Technology
- 05
Global Sourcing/Procurement
- 06
Cleanroom Assembly (ISO 14644-1 Class 7/8)
- 07
End-of-Line Testing
- 08
Packaging incl. IML
- 09
Logistics
Materials & Processes
Plastic
Base material for injection-molded parts, assemblies and medical technology components in all lot sizes.
Highly transparent glass
Combined with plastic into multi-material parts such as autoclavable eye funnels without adhesive bonding.
Metal
Third material in the fully automated multi-material manufacturing process, e.g. for the TecPart-awarded eye funnel.
In-Mold Labeling
Labeling of packaging and components directly during the injection molding process.
Injection Molding (medtech-optimized)
Core process for plastic parts according to medtech directives, with separate medical production.
Cleanroom Manufacturing ISO 14644-1 Class 7/8
Manual and semi-automated assembly of complex components by trained specialists.
End-of-Line Testing
Inspection and quality assurance of finished assemblies before packaging and delivery.
Toolmaking/Tool Design
In-house tool design and tool manufacturing for injection molding production.
Sites
Helmbrechts
DEHeadquarters / Production & Cleanroom Manufacturing
- Materials
- Plastic, Glass, Metal
- Injection Molding Machines
- Toolmaking
- Cleanroom ISO 14644-1 Class 7/8
Sparneck (KH Foliotec)
DEProduction
Chodov (KH Czechia)
CZProduction
Suzhou (KH Unikun)
CNProduction
Querétaro (KH Mexico)
MXProduction
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Injection MoldingPlastic | – | – | – | – | Plastic, Glass, Metal (material combination) |
| Toolmaking (Tool shop)Engineering | – | – | – | – | – |
| Development / EngineeringEngineering | – | – | – | – | – |
| Surface TechnologySurface | – | – | – | – | – |
| Cleanroom Assembly (manual and semi-automated, ISO 14644-1 Class 7/8)Assembly | – | – | – | – | – |
| End-of-Line Testing / InspectionTesting | – | – | – | – | – |
| PackagingAssembly | – | – | – | – | – |
| Logistics / Global ProcurementAssembly | – | – | – | – | – |
| Fully automated manufacturing process for multi-material parts (eye funnel made of glass, metal andJoining | – | – | – | – | Glass, Metal, Plastic |
| In-Mold Labeling (IML)Plastic | – | – | – | – | Plastic |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Injection Molding Machines | – | – | – | – | Helmbrechts, Germany |
Additional services
Reference customers
Quality & Certification
KH Medical is certified to EN ISO 13485 and IATF/TS 16949; assembly takes place in cleanrooms according to ISO 14644-1 classes 7 and 8 with manual and semi-automated production and final end-of-line testing. MDR-compliant end-to-end monitoring also includes subcontractors.
| Evidence | Helmbrechts |
|---|---|
| EN ISO 13485 | |
| IATF / TS 16949 | |
| ISO 14644-1 Class 7/8 (Cleanroom) |
History
- 1958
Foundation of the KH Group (Kunststoff Helmbrechts), according to its own statements successfully on the market since 1958
- 1980er
Start of supplying the healthcare/medical technology industry
- 2019
Foundation of KH Medical GmbH
- 2024
Delivery of the 150,000th single-use endoscope; TecPart Award for the autoclavable eye funnel made of glass, metal and plastic