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SUNTECH MEDICAL, INC.

United States·US-MF-000002189

Last updated September 17, 2026

Information

Country: United States
Address: 5827, S. Miami Boulevard, Morrisville, United States
Website: www.suntechmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Tonia Bryant
EUDAMED SRN: US-MF-000002189
FDA FEI Number: 1036863
DUNS Number: —

Catalogue (1058)

Page 3 of 22

Device	Model / Reference	Registries	Class	Status
Orbit K	98-0061-05	FDA UDI	Class II	Active
All Purpose Cuff	98-0084-74	FDA UDI	Class II	Active
All Purpose Cuff	98-0095-04	FDA UDI	Class II	Active
Durable BP Cuff	98-0601-01	FDA UDI	Class II	Active
Durable BP Cuff	98-0600-16	FDA UDI	Class II	Active
Durable BP Cuff	98-0600-E0	FDA UDI	Class II	Active
Disposable Cuff	98-0800-80	FDA UDI	Class II	Unknown
All Purpose Cuff	98-0085-17	FDA UDI	Class II	Active
Disposable cuff	98-0399-C0	FDA UDI	Class II	Active
Disposable Cuff	98-0400-7A	FDA UDI	Class II	Active
Durable BP Cuff	98-0609-01	FDA UDI	Class II	Active
Orbit	98-0063-13	FDA UDI	Class II	Active
All Purpose Cuff	98-0084-98	FDA UDI	Class II	Active
All Purpose Cuff	98-0084-47	FDA UDI	Class II	Active
All Purpose Cuff	98-0085-06	FDA UDI	Class II	Active
Cable, Sp02, LPXpod, 2m	91-0125-01	FDA UDI	Class II	Active
Disposable Cuff	98-0400-85	FDA UDI	Class II	Active
Disposable Cuff	98-0800-13	FDA UDI	Class II	Unknown
Orbit	98-0123-03	FDA UDI	Class II	Active
Disposable Cuff	98-0800-45	FDA UDI	Class II	Unknown
Durable BP Cuff	98-0600-G6	FDA UDI	Class II	Unknown
All Purpose Cuff	98-0085-11	FDA UDI	Class II	Active
Orbit K	98-0062-03	FDA UDI	Class II	Unknown
All Purpose Cuff	98-0234-03	FDA UDI	Class II	Unknown
Disposable Cuff	98-0400-02	FDA UDI	Class II	Active
Disposable Cuff	98-0800-30	FDA UDI	Class II	Unknown
Disposable Cuff	98-0400-E8	FDA UDI	Class II	Active
Disposable Cuff	98-0800-25	FDA UDI	Class II	Unknown
Disposable Cuff	98-0800-17	FDA UDI	Class II	Unknown
Tango M2 to CH2000 RS232 Interface Cable, RoHS	91-0065-01	FDA UDI	Class II	Active
Oscar 2, Model 250D	99-0233-07	FDA UDI	Class II	Active
Disposable Cuff	98-0800-81	FDA UDI	Class II	Unknown
Norav	99-0233-10	FDA UDI	Class II	Active
Tango M2	99-0088-15	FDA UDI	Class II	Active
247	99-0061-00	FDA UDI	Class II	Active
Disposable Cuff	98-0400-E3	FDA UDI	Class II	Active
Durable BP Cuff	98-0600-00	FDA UDI	Class II	Active
Disposable Cuff	98-0800-09	FDA UDI	Class II	Unknown
All Purpose Cuff	98-0084-03	FDA UDI	Class II	Active
Tango M2	99-0132-10	FDA UDI	Class II	Active
Disposable cuff	98-0699-03	FDA UDI	Class II	Active
Durable BP Cuff	98-0606-05	FDA UDI	Class II	Active
Durable BP Cuff	98-0600-17	FDA UDI	Class II	Active
SunTech	91-0087-00	FDA UDI	Class II	Active
All Purpose Cuff	98-0080-16	FDA UDI	Class II	Active
Durable BP Cuff	98-0608-05	FDA UDI	Class II	Active
Durable BP Cuff	98-0600-C6	FDA UDI	Class II	Unknown
All Purpose Cuff	98-0085-44	FDA UDI	Class II	Active
All Purpose Cuff	98-0085-20	FDA UDI	Class II	Active
Durable BP Cuff	98-0600-87	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 20, 2020	Z-2429-2020	—	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.
Dec 11, 2019	Z-0810-2020	—	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.
Jun 3, 2019	Z-2277-2019	—	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.