MIDMARK CORPORATION
Registration 1523530FEI 1523530Versailles, OH
Owner/operator: MIDMARK CORP.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Repack or Relabel 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
- 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
- 23
- Added, last 12 months
- 2
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 23
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| DPS | Midmark IQecg ElectrocardiographElectrocardiograph | Class 2 | 21 CFR 870.2340 | K103640 |
| FLE | Midmark and Ritter M9 and M11 UltraClaveSterilizer, Steam | Class 2 | 21 CFR 880.6880 | K163337 |
| FLE | Midmark M9® and M11® Steam SterilizerSterilizer, Steam | Class 2 | 21 CFR 880.6880 | K233026 |
| DXN | IQvitalsSystem, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 21 CFR 870.1130 | K100913 |
| MUH | Midmark Intraoral Digital SensorSystem, X-Ray, Extraoral Source, Digital | Class 2 | 21 CFR 872.1800 | K112380 |
| MUH | PROGENY IMAGING SOFTWARESystem, X-Ray, Extraoral Source, Digital | Class 2 | 21 CFR 872.1800 | K070664 |
| DRG | Midmark Digital ECGTransmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | 21 CFR 870.2910 | K220526 |
| EHD | Preva, Extraoral X-Ray SystemUnit, X-Ray, Extraoral With Timer | Class 2 | 21 CFR 872.1800 | K043092 |
| NOD | Midmark Hand Surgery, Articulating and Fixed ArmboardBoard, Arm (With Cover), Non-Sterile | Class 1 | 21 CFR 878.3910 | — |
| FML | RITTERChair, Blood Donor | Class 1 | 21 CFR 880.6140 | — |
| NRU | ElevanceChair, Dental, Without Operative Unit | Class 1 | 21 CFR 872.6250 | — |
| FRK | MidmarkChair, Examination And Treatment | Class 1 | 21 CFR 880.6140 | — |
and 11 more on your full dossier
What changed
- Nov 17, 2025Listing added: EIA — Midmark Dental Delivery System (K251626)
- Feb 18, 2026Listing added: EBR — Midmark Cuspidor