CS MEDICAL LLC
Registration 3005698329FEI 3005698329Creedmoor, NC
Owner/operator: CS MEDICAL LLC
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- Dec 23Holiday week8 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 11
- Added, last 12 months
- 0
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 11
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| PSW | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck CIHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class 2 | 21 CFR 892.1570 | K230381 |
| PSW | TEEClean® Automated TEE Probe Cleaner Disinfector with TEEZyme® Cleaner and TD-5® or TD-8® High Level DisinfectantsHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class 2 | 21 CFR 892.1570 | K182891 |
| PSW | TD-100 Automated TEE Probe Disinfector and TD-5 High-Level Disinfectant SystemHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class 2 | 21 CFR 892.1570 | K051305 |
| PSW | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical IndicatorHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class 2 | 21 CFR 892.1570 | K233049 |
| PSW | TD-100 Automated TEE Probe Disinfector with TD-5 and TD-8 High-Level Disinfectant SystemHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class 2 | 21 CFR 892.1570 | K160921 |
| PSW | TD 200 Automated TEE Probe Disinfector and TD-12 High-Level DisinfectantHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class 2 | 21 CFR 892.1570 | K192228 |
| JOJ | QwikCheck Chemical IndicatorIndicator, Physical/Chemical Sterilization Process | Class 2 | 21 CFR 880.2800 | K192445 |
| JOJ | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical IndicatorIndicator, Physical/Chemical Sterilization Process | Class 2 | 21 CFR 880.2800 | K233049 |
| MED | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical IndicatorSterilant, Medical Devices | Class 2 | 21 CFR 880.6885 | K233049 |
| MED | TD 200 Automated TEE Probe Disinfector and TD-12 High-Level DisinfectantSterilant, Medical Devices | Class 2 | 21 CFR 880.6885 | K192228 |
| NHV | CS-200895 DSU-H Ultrafilter Installation KitSystem, Water Purification, General Medical Use | Class 2 | 21 CFR 876.5665 | K141731 |
What changed
Nothing added in the last twelve months, and no change seen on the record yet.