SunTech Medical, Inc

• Patient Hose 91-0028-23 Ref 91-0028-23

  Class II FDA UDI Active

• Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), Siemens 91-0032-33 Ref 91-0032-33

  Class II FDA UDI Active

• Straight Gray Hose, Female Luer to Female Bayonet, 9.8ft (3m), Siemens 91-0032-34 Ref 91-0032-34

  Class II FDA UDI Active

• All Purpose Cuff 98-0097-30 Ref 98-0097-30

  Class II FDA UDI Active

• Disposable Cuff 98-0800-2C Ref 98-0800-2C

  Class II FDA UDI

• SunTech APC 98-0084-35 Ref 98-0084-35

  Class II FDA UDI Active

• Disposable Cuff 98-0400-47 Ref 98-0400-47

  Class II FDA UDI Active

• Disposable Cuff 98-0700-02 Ref 98-0700-02

  Class II FDA UDI

• Disposable Cuff 98-0800-3A Ref 98-0800-3A

  Class II FDA UDI

• SunTech 99-0027-39 Ref 99-0027-39

  Class II FDA UDI Active

• 247 99-0098-00 Ref 99-0098-00

  Class II FDA UDI Active

• Durable BP Cuff 98-0600-85 Ref 98-0600-85

  Class II FDA UDI Active

• Disposable Cuff 98-0800-60 Ref 98-0800-60

  Class II FDA UDI

• Durable BP Cuff 98-0600-FA Ref 98-0600-FA

  Class II FDA UDI Active

• All Purpose Cuff 98-0085-16 Ref 98-0085-16

  Class II FDA UDI Active

• Disposable Cuff 98-0400-38 Ref 98-0400-38

  Class II FDA UDI Active

• Nonin 52-0003-00 Ref 52-0003-00

  Class II FDA UDI Active

• Disposable Cuff 98-0400-99 Ref 98-0400-99

  Class II FDA UDI Active

• SunTech 98-0239-21 Ref 98-0239-21

  Class II FDA UDI Active

• Disposable Cuff 97-1108-09 Ref 97-1108-09

  Class II FDA UDI Active

• 247 99-0121-00 Ref 99-0121-00

  Class II FDA UDI Active

• All Purpose Cuff 98-0092-01 Ref 98-0092-01

  Class II FDA UDI Active

• Disposable Cuff 98-0400-C2 Ref 98-0400-C2

  Class II FDA UDI

• 8 pin mini din Splitter Cable 91-0069-00 Ref 91-0069-00

  Class II FDA UDI Active

• Disposable Cuff 98-0400-83 Ref 98-0400-83

  Class II FDA UDI Active

• All Purpose Cuff 98-0114-01 Ref 98-0114-01

  Class II FDA UDI Active

• All Purpose Cuff 98-0080-19 Ref 98-0080-19

  Class II FDA UDI Active

• Disposable Cuff 98-0400-55 Ref 98-0400-55

  Class II FDA UDI Active

• All Purpose Cuff 98-0097-01 Ref 98-0097-01

  Class II FDA UDI Active

• Disposable Cuff 98-0800-6K Ref 98-0800-6K

  Class II FDA UDI

• Disposable Cuff 98-0700-05 Ref 98-0700-05

  Class II FDA UDI

• Disposable Cuff 98-0400-89 Ref 98-0400-89

  Class II FDA UDI Active

• Disposable Cuff 98-0800-38 Ref 98-0800-38

  Class II FDA UDI

• All Purpose Cuff 98-0080-15 Ref 98-0080-15

  Class II FDA UDI Active

• SunTech 98-0093-23 Ref 98-0093-23

  Class II FDA UDI Active

• Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation 98-0062-40 Ref 98-0062-40

  Class II FDA UDI Active

• Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation 98-0062-41 Ref 98-0062-41

  Class II FDA UDI Active

• Disposable Cuff 98-0400-95 Ref 98-0400-95

  Class II FDA UDI Active

• SunTech 98-0253-01 Ref 98-0253-01

  Class II FDA UDI Active

• Disposable Cuff 98-0400-28 Ref 98-0400-28

  Class II FDA UDI Active

• Tango M2 99-0132-07 Ref 99-0132-07

  Class II FDA UDI Active

• Disposable Cuff 98-0400-A7 Ref 98-0400-A7

  Class II FDA UDI Active

• All Purpose Cuff 98-0084-06 Ref 98-0084-06

  Class II FDA UDI Active

• Oscar 2, Model 250D 99-0233-01 Ref 99-0233-01

  Class II FDA UDI Active

• All Purpose Cuff 98-0085-40 Ref 98-0085-40

  Class II FDA UDI Active

• Durable BP Cuff 98-0600-13 Ref 98-0600-13

  Class II FDA UDI Active

• Disposable Cuff 98-0400-C6 Ref 98-0400-C6

  Class II FDA UDI

• Oscar 2 99-0133-52 Ref 99-0133-52

  Class II FDA UDI Active

• Oscar 2 99-0133-04 Ref 99-0133-04

  Class II FDA UDI Active

• Eclipse cuff 98-0068-09 Ref 98-0068-09

  Class II FDA UDI Active

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

Website

www.suntechmed.com

LinkedIn

linkedin.com/company/78115

Facebook

facebook.com/SunTechVetBP

Email

[email protected]

Phone

+1-919-654-2300

PRRC contact

Tonia Bryant(public in EUDAMED)

1 certificate·1 valid, 0 expired·MDR 1·next expiry 27 Nov 2027

• 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

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