BLUE LINE STERILIZATION SERVICES
Registration 3009905888FEI 3009905888Novato, CA
Owner/operator: Blue Line Sterilization Services LLC
- Sterilize Medical Device for Another Party (Contract Sterilizer)
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 22
- Added, last 12 months
- 5
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 22
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| LYK | Vena MicroAngioscope SystemAngioscopeAdded Feb 25, 2026 | Class 2 | 21 CFR 876.1500 | — |
| NCR | The Fugo Blade For GlaucomaApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | Class 2 | 21 CFR 886.4100 | — |
| NCR | Fugo Blade For Peripheral Iridotomy, modApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | Class 2 | 21 CFR 886.4100 | — |
| NCR | The Fugo BladeApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | Class 2 | 21 CFR 886.4100 | — |
| DQY | MicroCross CatheterCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | — |
| DQY | MultiCrossCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | — |
| DQY | CenterCross CatheterCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | — |
| JXI | ConformaWrapCuff, NerveAdded Jun 17, 2026 | Class 2 | 21 CFR 882.5275 | — |
| JXI | Nerve TapeCuff, NerveAdded Jun 17, 2026 | Class 2 | 21 CFR 882.5275 | — |
| KRD | Medusa Vascular PlugDevice, Vascular, For Promoting Embolization | Class 2 | 21 CFR 870.3300 | — |
| GEI | SIRA RFA Electrosurgical DeviceElectrosurgical, Cutting & Coagulation & AccessoriesAdded May 15, 2026 | Class 2 | 21 CFR 878.4400 | — |
| MAI | Fastener, Fixation, Biodegradable, Soft TissueOrthopedic | Class 2 | 21 CFR 888.3030 | — |
and 10 more on your full dossier
What changed
- Feb 25, 2026Listing added: LYK — Vena MicroAngioscope System
- Jun 17, 2026Listing added: JXI — ConformaWrap
- Jun 17, 2026Listing added: JXI — Nerve Tape
- May 15, 2026Listing added: GEI — SIRA RFA Electrosurgical Device
- Jun 26, 2026Listing added: GAT — Suture, nonabsorbable, synthetic, polyethylene