Contract sterilizerEurofins Infinity Laboratory Group Inc. (San Jose, CA)CaliforniaCardiovascularEar, nose and throatGastroenterology and urologyGeneral and plastic surgeryNeurologyObstetrics and gynecologyOrthopedicRadiologyHematologyClass IIClass III
Eurofins Infinity Laboratory Group Inc.
Contract sterilizer · San Jose, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3013944123 (openFDA record; or search FDA's registration database)
- FEI number
- 3013944123
- Registered for
- FDA registration year 2026
- Establishment types
- Contract sterilizer
- Owner or operator
- Eurofins - Infinity Laboratory Group Inc. (FDA owner/operator no. 10080298)
- Registered address
- 1836 Stone Ave, San Jose, CA 95125
- Contract listings
- 47 device listings, 34 product codes, first listed Jan 25, 2021
- 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 |
|---|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract sterilization | Jan 25, 2021 |
| EOX | Esophagoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract sterilization | Jan 25, 2021 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract sterilization | Sep 7, 2021 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract sterilization | Mar 16, 2023 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract sterilization | Mar 16, 2023 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract sterilization | Jan 25, 2021 |
| FWP | Prosthesis, Chin, Internal | Class II | General and plastic surgery | Contract sterilization | Jan 25, 2021 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Feb 5, 2021 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Jan 25, 2021 |
| GWM | Device, Monitoring, Intracranial Pressure | Class II | Neurology | Contract sterilization | Jan 25, 2021 |
| GXH | Device, Surgical, Cryogenic | Class II | Neurology | Contract sterilization | Jan 25, 2021 |
| HCG | Device, Neurovascular Embolization | Class II | Neurology | Contract sterilization | Jan 25, 2021 |
| HIH | Hysteroscope (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Jan 25, 2021 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Feb 5, 2021 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract sterilization | Aug 21, 2024 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract sterilization | Apr 2, 2026 |
| JXG | Shunt, Central Nervous System And Components | Class II | Neurology | Contract sterilization | Jan 25, 2021 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | Class II | General and plastic surgery | Contract sterilization | Jan 25, 2021 |
| KRD | Device, Vascular, For Promoting Embolization | Class II | Cardiovascular | Contract sterilization | Jan 25, 2021 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Class II | Cardiovascular | Contract sterilization | Jan 25, 2021 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class II | Cardiovascular | Contract sterilization | May 7, 2026 |
| LZK | Implant, Malar | Class II | General and plastic surgery | Contract sterilization | Jan 25, 2021 |
| MJN | Catheter, Intravascular Occluding, Temporary | Class II | Cardiovascular | Contract sterilization | Jan 25, 2021 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract sterilization | Dec 29, 2022 |
| MUD | Oximeter, Tissue Saturation | Class II | Cardiovascular | Contract sterilization | Jan 25, 2021 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Class II | Cardiovascular | Contract sterilization | Jan 25, 2021 |
| OBJ | Catheter, Ultrasound, Intravascular | Class II | Cardiovascular | Contract sterilization | Apr 2, 2026 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | May 4, 2021 |
| OWB | Interventional Fluoroscopic X-Ray System | Class II | Radiology | Contract sterilization | Dec 13, 2022 |
| PZP | Fluid Jet Removal System | Class II | General and plastic surgery | Contract sterilization | Aug 21, 2024 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Class II | Cardiovascular | Contract sterilization | Dec 23, 2022 |
| QJP | Catheter, Percutaneous, Neurovasculature | Class II | Cardiovascular | Contract sterilization | Jun 28, 2022 |
| QKA | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | Class II | Gastroenterology and urology | Contract sterilization | Apr 2, 2026 |
| QPT | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence | Class III | Gastroenterology and urology | Contract sterilization | Jun 27, 2022 |