Contract manufacturerCLAYENS Crystal Lake , LLC (Crystal Lake, IL)IllinoisGeneral hospitalGastroenterology and urologyClass IIClass I
CLAYENS Crystal Lake , LLC
Contract manufacturer · Crystal Lake, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3025432964 (openFDA record; or search FDA's registration database)
- FEI number
- 3025432964
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- CLAYENS NP USA, INC (FDA owner/operator no. 10087832)
- Registered address
- 815 Tek Dr,, Crystal Lake, IL 60014
- Contract listings
- 8 device listings, 6 product codes, first listed Apr 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 |
|---|---|---|---|---|---|
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Apr 19, 2023 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract manufacturing | Apr 16, 2023 |
| KYW | Container, Liquid Medication, Graduated | Class I | General hospital | Contract manufacturing | Apr 19, 2023 |
| MMK | Container, Sharps | Class II | General hospital | Contract manufacturing | Apr 19, 2023 |
| NGT | Saline, Vascular Access Flush | Class II | General hospital | Contract manufacturing | Apr 10, 2024 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Class II | Gastroenterology and urology | Contract manufacturing | Mar 17, 2026 |