German manufacturer of medical devices for sleep diagnostics, oxygen supply, neurophysiology and cardiology.
CNSAC MedShop GmbH
97288 TheilheimNew on Amplifa
About CNSAC MedShop
CNSAC MedShop GmbH, based in Theilheim (Bavaria), is a German medical technology manufacturer focusing on single-use and reusable medical devices for sleep diagnostics, oxygen therapy, neurophysiology and cardiology. The product portfolio includes adhesive and cup electrodes made of silver/silver chloride and gold, EMG needle electrodes, EEG caps for routine, long-term and video EEG, PSG and research applications, as well as nasal cannulas, filters, masks, sensors and consumables. In addition to its standard product range, the company develops custom solutions and OEM products for partners in diagnostics and medical technology. The products are manufactured according to international standards and are in use in global markets with approvals including CE/MDR, FDA, PMDA, Health Canada and TGA. According to the company, the products support the diagnosis and care of more than two million patients every year. Distribution takes place worldwide with international delivery capability and dealer support.
- Site
- Theilheim
- Processes
- Development and manufacture of custom medical devices (OEM solutions), Manufacture of single-use and reusable medical devices (electrodes, EEG caps), custom solutions / OEM development for diagnostics and medical technology, worldwide distribution, international shipping, dealer support
- Materials
- Silver/Silver chloride, Gold, Plastic
- Certificates
- EN ISO 13485:2016, CE/MDR, FDA (USA), PMDA (Japan), Health Canada, TGA (Australia)
- Industries
- Sleep diagnostics, Oxygen therapy/supply, Neurophysiology, Cardiology, Diagnostics & Therapy, Medical technology
- 01
Development / OEM engineering
- 02
Manufacturing of single-use and reusable medical devices
- 03
Quality control according to ISO 13485
- 04
Regulatory approval (CE/MDR, FDA, etc.)
- 05
Worldwide distribution
- 06
Dealer and OEM support
Materials
Silver/Silver chloride
Used for reusable and single-use cup electrodes in neurophysiology.
Gold
Material for reusable cup electrodes with high signal quality.
Plastic
Material used for EEG caps, nasal cannulas and single-use products.
Locations
Theilheim
DEHeadquarters
- Materials
- Ag/AgCl, Gold, Plastic
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development and manufacture of custom medical devices (OEM solutions)Engineering | – | – | – | – | – |
| Manufacture of single-use and reusable medical devices (electrodes, EEG caps)Assembly | – | – | – | – | Ag/AgCl, Gold, Plastic |
Additional services
Quality & Certification
CNSAC MedShop GmbH has a quality management system certified to EN ISO 13485:2016, certified by TÜV SÜD Product Service. The products meet regulatory requirements for approvals such as CE/MDR, FDA, PMDA, Health Canada and TGA.
| Evidence | Theilheim |
|---|---|
| EN ISO 13485:2016 | |
| CE/MDR | |
| FDA (USA) | |
| PMDA (Japan) | |
| Health Canada | |
| TGA (Australia) |