Contract manufacturerContract sterilizerBOULDER BIOMED LLC (Boulder, CO)ColoradoCardiovascularGastroenterology and urologyGeneral hospitalGeneral and plastic surgeryNeurologyOrthopedicRadiologyHematologyClass IIClass IIIClass I
BOULDER BIOMED LLC
Contract manufacturer and sterilizer · Boulder, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3015151147 (openFDA record; or search FDA's registration database)
- FEI number
- 3015151147
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Contract sterilizer
- Owner or operator
- Boulder BioMed dba Boulder iQ (FDA owner/operator no. 10058905)
- Registered address
- 5421 Western Avenue, Boulder, CO 80301
- Contract listings
- 30 device listings, 30 product codes, first listed Mar 16, 2023
- 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 |
|---|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Class II | Cardiovascular | Contract sterilization | Dec 9, 2024 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract manufacturing | Oct 23, 2023 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract sterilization | Oct 23, 2023 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract sterilization | Jul 10, 2026 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Class III | Gastroenterology and urology | Contract sterilization | Aug 29, 2025 |
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Mar 16, 2023 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Mar 16, 2023 |
| GAB | Needle, Suturing, Disposable | Class I | General and plastic surgery | Contract manufacturing | Apr 7, 2025 |
| GAB | Needle, Suturing, Disposable | Class I | General and plastic surgery | Contract sterilization | Apr 7, 2025 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Oct 20, 2023 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Oct 20, 2023 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract sterilization | Oct 20, 2023 |
| GWM | Device, Monitoring, Intracranial Pressure | Class II | Neurology | Contract manufacturing | Oct 23, 2023 |
| GWM | Device, Monitoring, Intracranial Pressure | Class II | Neurology | Contract sterilization | Oct 20, 2023 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract manufacturing | Oct 20, 2023 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract sterilization | Oct 20, 2023 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Oct 20, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Apr 7, 2025 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Apr 7, 2025 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Sep 16, 2024 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract sterilization | Sep 16, 2024 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Sep 16, 2024 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Sep 16, 2024 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract sterilization | Oct 20, 2023 |
| JXG | Shunt, Central Nervous System And Components | Class II | Neurology | Contract manufacturing | Oct 23, 2023 |
| JXG | Shunt, Central Nervous System And Components | Class II | Neurology | Contract sterilization | Oct 20, 2023 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Dec 9, 2024 |
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract manufacturing | Oct 20, 2023 |
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract sterilization | Oct 20, 2023 |
| KRD | Device, Vascular, For Promoting Embolization | Class II | Cardiovascular | Contract manufacturing | Feb 6, 2026 |
| KRD | Device, Vascular, For Promoting Embolization | Class II | Cardiovascular | Contract sterilization | Feb 6, 2026 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract sterilization | Dec 9, 2024 |
| LRW | Scissors, General, Surgical | Class I | General and plastic surgery | Contract manufacturing | Mar 14, 2025 |
| LRW | Scissors, General, Surgical | Class I | General and plastic surgery | Contract sterilization | Mar 14, 2025 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Oct 23, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract sterilization | Oct 23, 2023 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Oct 20, 2023 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Oct 20, 2023 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Sep 16, 2024 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Sep 16, 2024 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Oct 20, 2023 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract sterilization | Oct 20, 2023 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Oct 20, 2023 |
| OUH | Skin Resurfacing Rf Applicator | Class II | General and plastic surgery | Contract sterilization | Oct 20, 2023 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract sterilization | Oct 20, 2023 |
| SBF | Orthopedic Augmented Reality | Class II | Neurology | Contract sterilization | Dec 9, 2024 |