Device Desk

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FDA device establishment · Mahwah, NJ

This page shows the yearly renewal for this site, from FDA’s public record.

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Renewal dossierDD-2221819As of September 30, 2026

MINDRAY DS USA, Inc.

Registration 2221819FEI 2221819Mahwah, NJ

Owner/operator: Mindray DS USA, Inc.

  • Complaint File Establishment per 21 CFR 820.198
  • 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.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
290
Added, last 12 months
63

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

  1. 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 process

  2. Wait 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 process

  3. Renew 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 listing

  4. Review 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 290

CodeDeviceClassRegulationPremarket
DSJBeneVision N Series Patient MonitorAlarm, Blood-PressureClass 221 CFR 870.1100K213799
DSJePM 10A MonitorAlarm, Blood-PressureAdded Sep 2, 2026Class 221 CFR 870.1100—
DRQBeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70Amplifier And Signal Conditioner, Transducer SignalAdded Jun 1, 2026Class 221 CFR 870.2060—
DRQBeneVision Central Monitoring System with Telemetry - TD60 and TM80, and accessoriesAmplifier And Signal Conditioner, Transducer SignalClass 221 CFR 870.2060K183238
CCKBeneVision N Series Patient MonitorAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K213799
CCKA3 Anesthesia Delivery SystemAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K123211
CCKA8 Anesthesia Delivery SystemAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400—
CCKA4 Anesthesia SystemAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K171311
CCKAccutorr 7Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K182821
CCKePM 10A MonitorAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Sep 2, 2026Class 221 CFR 868.1400—
CCKA7 Anesthesia SystemAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K171292
CCKAccutorr 7Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K170712

and 278 more on your full dossier

What changed

  • Sep 2, 2026Listing added: DSJ — ePM 10A Monitor
  • Jun 1, 2026Listing added: DRQ — BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70
  • Sep 2, 2026Listing added: CCK — ePM 10A Monitor
  • Sep 2, 2026Listing added: CCK — A4 Anesthesia System
  • Sep 2, 2026Listing added: NHO — A4 Anesthesia System
  • Sep 2, 2026Listing added: CBQ — ePM 10A Monitor
  • Sep 2, 2026Listing added: CBQ — A4 Anesthesia System
  • Sep 2, 2026Listing added: CBS — ePM 10A Monitor
  • Sep 2, 2026Listing added: CBS — A4 Anesthesia System
  • Sep 2, 2026Listing added: NHQ — A4 Anesthesia System
  • Sep 2, 2026Listing added: CBR — ePM 10A Monitor
  • Sep 2, 2026Listing added: CBR — A4 Anesthesia System
  • Sep 2, 2026Listing added: CCL — ePM 10A Monitor
  • Sep 2, 2026Listing added: CCL — A4 Anesthesia System
  • Sep 2, 2026Listing added: NHP — A4 Anesthesia System
  • Sep 2, 2026Listing added: ORT — ePM 10A Monitor
  • Sep 2, 2026Listing added: ORT — A4 Anesthesia System
  • Sep 2, 2026Listing added: DSK — ePM 10A Monitor
  • Sep 2, 2026Listing added: DXG — ePM 10A Monitor
  • Sep 2, 2026Listing added: FLL — ePM 10A Monitor
  • Sep 2, 2026Listing added: DSI — ePM 10A Monitor
  • Sep 2, 2026Listing added: GXY — ePM 10A Monitor
  • Sep 2, 2026Listing added: BSZ — A4 Anesthesia System
  • Sep 2, 2026Listing added: OLW — A4 Anesthesia System
  • Sep 2, 2026Listing added: OLW — ePM 10A Monitor
  • Jun 1, 2026Listing added: DRT — BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70
  • Sep 2, 2026Listing added: DRT — ePM 10A Monitor
  • Sep 2, 2026Listing added: MHX — ePM 10A Monitor
  • Jun 1, 2026Listing added: MHX — BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70
  • Sep 2, 2026Listing added: MLD — ePM 10A Monitor
  • Sep 2, 2026Listing added: OLT — A4 Anesthesia System
  • Sep 2, 2026Listing added: OLT — ePM 10A Monitor
  • Sep 2, 2026Listing added: DQA — ePM 10A Monitor
  • Jun 1, 2026Listing added: DQA — BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70
  • Sep 2, 2026Listing added: DPZ — ePM 10A Monitor
  • Jun 1, 2026Listing added: DSB — BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70
  • Sep 2, 2026Listing added: OMC — ePM 10A Monitor
  • Sep 2, 2026Listing added: OMC — A4 Anesthesia System
  • Sep 2, 2026Listing added: KOI — ePM 10A Monitor
  • Sep 2, 2026Listing added: KOI — A4 Anesthesia System
  • Jun 1, 2026Listing added: MNT — SV70 Ventilator
  • Jun 1, 2026Listing added: IYN — MX3 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: IYN — ViewMate Multi Ultrasound System
  • Jun 1, 2026Listing added: IYN — MX7 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: IYN — Resona A20 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: IYN — ViewMate Multi Ultrasound System (VMM-ICE-01)
  • Jun 1, 2026Listing added: IYN — Hepatus 5 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: IYO — ViewMate Multi Ultrasound System
  • Jun 1, 2026Listing added: IYO — ViewMate Multi Ultrasound System (VMM-ICE-01)
  • Jun 1, 2026Listing added: IYO — MX3 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: IYO — MX7 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: IYO — Resona A20 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: IYO — Hepatus 5 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: DXN — BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70
  • Sep 2, 2026Listing added: DXN — ePM 10A Monitor
  • Jun 1, 2026Listing added: MSX — BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70
  • Jun 1, 2026Listing added: ITX — Hepatus 5 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: ITX — ViewMate Multi Ultrasound System (VMM-ICE-01)
  • Jun 1, 2026Listing added: ITX — ViewMate Multi Ultrasound System
  • Jun 1, 2026Listing added: ITX — MX3 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: ITX — MX7 Diagnostic Ultrasound System
  • Jun 1, 2026Listing added: ITX — Resona A20 Diagnostic Ultrasound System
  • Dec 8, 2025Listing added: CBK — SV700 Ventilator (K243767)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

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