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SunTech Medical, Inc

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000002189

Devices
1,053
Registrations
EUDAMEDFDA
FDA recalls
3

Catalogue1,053

Newest first, rows 151-200 of 1,053

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Rows 151-200 of 1,053

Showing 151-200 of 1,053

Company details

EUDAMED SRN
US-MF-000002189
DUNS number
148191133
EUDAMED status
Active
EUDAMED registered name
SunTech Medical, Inc
EUDAMED abbreviated name
SMI
Registered address
5827, S. Miami Boulevard, 27560, Morrisville, United States
Phone
+1-919-654-2300
PRRC contact
Tonia Bryant(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 27 Nov 2027

EUDAMED certificates (1)

Intertek Medical Notified Body AB 2862 1 certificate

  • 28620152041 Active

    Quality management system EU MDR

    Issued
    7 Jun 2023
    Expires
    27 Nov 2027

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 2
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2020

    • 20 Apr 2020 Z-2429-2020 Class II Terminated The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.via FDA establishment SUNTECH MEDICAL, INC. Distribution: Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to…
      Full distribution text Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, United Kingdom, Vietnam.
      Submission number: K151520

  • 2019

    • 11 Dec 2019 Z-0810-2020 Class II Terminated The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.via FDA establishment SUNTECH MEDICAL, INC. Distribution: No US Distribution; Internationally distributed to France, S. America Submission number: K151520
    • 3 Jun 2019 Z-2277-2019 Class II Terminated Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.via FDA establishment SUNTECH MEDICAL, INC. Distribution: Pakistan Submission number: K080854

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Suntech Medical, Inc. MORRISVILLE, NC · US FEI 1036863

From the company website

Read 18 Oct 2026

As the experts in BP technology, we know that exceptional products don’t just happen. They are created with an extraordinary attention to detail, so that when you need accuracy and quality – we deliver. Every time. It’s our Legacy. It’s SunTech Medical. It’s The Difference in Clinical Grade.®

From the manufacturer's own website. Source

Frequently asked questions

How many devices does SunTech Medical, Inc have in the registry?

The registry currently lists 1053 devices for SunTech Medical, Inc. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for SunTech Medical, Inc?

FDA recall records list 3 recalls initiated by SunTech Medical, Inc, the most recent initiated on 20 Apr 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for SunTech Medical, Inc?

EUDAMED lists 1 certificate for SunTech Medical, Inc (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 7 Jun 2023.

Which FDA establishments are linked to SunTech Medical, Inc?

1 FDA establishment is linked to SunTech Medical, Inc in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.