Contract manufacturerTECAN CDMO SOLUTIONS MH, CORP. (Morgan Hill, CA)CaliforniaGastroenterology and urologyGeneral and plastic surgeryCardiovascularOphthalmicClinical chemistryGeneral hospitalMicrobiologyClass IIClass IIIClass IUnclassified
TECAN CDMO SOLUTIONS MH, CORP.
Contract manufacturer ยท Morgan Hill, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003537036 (openFDA record; or search FDA's registration database)
- FEI number
- 3003537036
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Tecan Group AG (FDA owner/operator no. 9050992)
- Registered address
- 18735 MADRONE PKWY., Morgan Hill, CA 95037
- Contract listings
- 12 device listings, 12 product codes, first listed Dec 10, 2013
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| EXY | Uroflowmeter | Class II | Gastroenterology and urology | Contract manufacturing | Nov 4, 2021 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology and urology | Contract manufacturing | Mar 1, 2023 |
| FKX | System, Peritoneal, Automatic Delivery | Class II | Gastroenterology and urology | Contract manufacturing | Aug 23, 2022 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Oct 8, 2021 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Class III | Cardiovascular | Contract manufacturing | Jun 8, 2023 |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | Gastroenterology and urology | Contract manufacturing | Oct 8, 2021 |
| OOE | Ophthalmic Femtosecond Laser | Class II | Ophthalmic | Contract manufacturing | Nov 10, 2021 |
| OOI | Real Time Nucleic Acid Amplification System | Class II | Clinical chemistry | Contract manufacturing | Feb 5, 2026 |
| OUG | Medical Device Data System | Class I | General hospital | Contract manufacturing | Oct 8, 2021 |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | Class I | Clinical chemistry | Contract manufacturing | Dec 10, 2013 |
| PHU | Intra-Abdominal Pressure Monitoring Device | Unclassified | General and plastic surgery | Contract manufacturing | Nov 4, 2021 |
| QUT | Deformability Cytometry For Sepsis Risk Assessment | Class II | Microbiology | Contract manufacturing | Jul 13, 2026 |