BIOMED MEDEQUIP INC.
Registration 1650347FEI 3002253377Rowlett, TX
Owner/operator: Biomed Medequip Inc.
- Manufacture Medical Device for Another Party (Contract Manufacturer)
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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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 8
- Added, last 12 months
- 8
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 8
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| CCK | Carbon Dioxide monitoring CTM EtCo2 sensorAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Mar 16, 2026 | Class 2 | 21 CFR 868.1400 | — |
| DXQ | Blood pressure cuffs (Adult/Pediatric/Infant/Neonate)Blood Pressure CuffAdded Mar 16, 2026 | Class 2 | 21 CFR 870.1120 | — |
| IKD | ECG Trunk cables and leadwires, Trunk Cables (IBP cables, Spo2 cables, Temp. Cables), Adaptors, Leg plate adaptorsCable, ElectrodeAdded Mar 19, 2026 | Class 2 | 21 CFR 890.1175 | — |
| DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)Cable, Transducer And Electrode, Patient, (Including Connector)Added Mar 16, 2026 | Class 2 | 21 CFR 870.2900 | — |
| FLL | TS series skin and general/oral temperature probesContinuous Measurement ThermometerAdded Mar 16, 2026 | Class 2 | 21 CFR 880.2910 | — |
| DRX | Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodesElectrode, ElectrocardiographAdded Mar 19, 2026 | Class 2 | 21 CFR 870.2360 | — |
| DQA | SS series reusable Spo2 sensors and SSD series disposable sensorsOximeterAdded Mar 16, 2026 | Class 2 | 21 CFR 870.2700 | — |
| JFC | Non Invasive Blood Pressure Measurement Hose; Reusable NIBP Hose Connection tubeSystem, Pressure Measurement, IntermittentAdded Mar 19, 2026 | Class 1 | 21 CFR 890.1600 | — |
What changed
- Mar 16, 2026Listing added: CCK — Carbon Dioxide monitoring CTM EtCo2 sensor
- Mar 16, 2026Listing added: DXQ — Blood pressure cuffs (Adult/Pediatric/Infant/Neonate)
- Mar 19, 2026Listing added: IKD — ECG Trunk cables and leadwires, Trunk Cables (IBP cables, Spo2 cables, Temp. Cables), Adaptors, Leg plate adaptors
- Mar 16, 2026Listing added: DSA — CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
- Mar 16, 2026Listing added: FLL — TS series skin and general/oral temperature probes
- Mar 19, 2026Listing added: DRX — Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodes
- Mar 16, 2026Listing added: DQA — SS series reusable Spo2 sensors and SSD series disposable sensors
- Mar 19, 2026Listing added: JFC — Non Invasive Blood Pressure Measurement Hose; Reusable NIBP Hose Connection tube