System, Perfusion, Kidney (KDN) contract manufacturers
18 US facilities list FDA product code KDN as a contract manufacturer (12) or contract sterilizer (6).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- System, Perfusion, Kidney
- Product code
- KDN (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 876.5880
- Classification panel
- Gastroenterology and urology
Where they are
Illinois 4 · Utah 3 · Michigan 2 · California 1 · Georgia 1 · Minnesota 1 · North Carolina 1 · New York 1 · Pennsylvania 1 · Tennessee 1 · Texas 1 · Wisconsin 1
All 18 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| AUGUST BIOSERVICES, LLC | 3017298490 | Contract manufacturer | Gastroenterology and urology | Nashville, TN | Not verified | Oct 21, 2026 |
| BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC. | 1067143 | Contract manufacturer | Gastroenterology and urology | Peachtree Corners, GA | Not verified | Oct 21, 2026 |
| BIOMERICS | 3008998256 | Contract manufacturer | Cardiovascular; Gastroenterology and urology; General hospital +3 more | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| Biovire, Inc. | 3011292417 | Contract manufacturer | Gastroenterology and urology; General hospital; Pathology | Brighton, MI | Not verified | Oct 21, 2026 |
| ILC Dover | 3038515260 | Contract manufacturer | Gastroenterology and urology | Lillington, NC | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1319660 | Contract sterilizer | Orthopedic; General and plastic surgery; Ophthalmic +10 more | Chester, NY | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1720929 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Sandy, UT | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1450662 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Libertyville, IL | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +13 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| LIFECYCLE BIOTECHNOLOGIES, LLC | 3020224798 | Contract manufacturer | Gastroenterology and urology | Cleburne, TX | Not verified | Oct 21, 2026 |
| MARIAN CHICAGO, INC. | 3010005578 | Contract manufacturer | Gastroenterology and urology | West Chicago, IL | Not verified | Oct 21, 2026 |
| PACKAGING COMPLIANCE MEDICAL, LLC | 3014967969 | Contract manufacturer | Orthopedic; General and plastic surgery; Gastroenterology and urology +6 more | Kentwood, MI | Not verified | Oct 21, 2026 |
| SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD. | 3000143502 | Contract manufacturer | Anesthesiology; Cardiovascular; Gastroenterology and urology +4 more | Somerset, WI | Not verified | Oct 21, 2026 |
| SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD. | 3010034260 | Contract manufacturer | Cardiovascular; Gastroenterology and urology; Neurology +3 more | Santa Rosa, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1420032 | Contract sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +5 more | Schaumburg, IL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1721676 | Contract sterilizer | Cardiovascular; Orthopedic; General and plastic surgery +12 more | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| TRICOR SYSTEMS | 1423929 | Contract manufacturer | Radiology; Gastroenterology and urology; Dental +1 more | Elgin, IL | Not verified | Oct 21, 2026 |
| US SPECIALTY FORMULATIONS | 3010680515 | Contract manufacturer | Gastroenterology and urology | Allentown, PA | Not verified | Oct 21, 2026 |
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