Regard™
Disposable Large Adult Long Cuff 33-41 CM
50manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (22), Zhejiang (13), Jiangsu (7). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| A&D Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Suntech Medical Devices (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shanghai Minhua Medical Apparatus Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Wenzhou Naisi Health Product Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 50. All 50 manufacturers in China registered for Blood Pressure Cuff
Record
| Listed by | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | DXQ |
| Device type | Blood Pressure Cuff |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1120 |
| 510(k) | K921997 |
| Record published | 2024-12-02 |
| Record revised | 2026-05-01 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 10, pack of 20, pack of 12 |
| Distribution end date | 2025-11-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BPNEO4-REG | In distribution | |
| RBPSMADLT-REG | In distribution | |
| DBPLGADLTL-REG | In distribution | |
| RBPADLTL-REG | In distribution | |
| DBPADLT-REG | In distribution | |
| BPNEO5-REG | In distribution | |
| DBPADLTL-REG | In distribution | |
| BPNEO3-REG | In distribution | |
| DBPSMADLT-REG | In distribution | |
| DBPLRGADLT-REG | In distribution | |
| RBPLRGADLT-REG | In distribution | |
| RBPTHIGH-REG | In distribution | |
| RBPLGADLTL-REG | In distribution | |
| BPNEO2-REG | In distribution | |
| RBPCHILD-REG | In distribution | |
| RBPADLT-REG | In distribution | |
| DBPCHILD-REG | In distribution | |
| BPNEO1-REG | In distribution | |
| DBPTHIGH-REG | In distribution | |
| 243436 | Withdrawn | |
| 243456 | Withdrawn | |
| 243439 | Withdrawn | |
| 243453 | Withdrawn | |
| 243450 | Withdrawn | |
| 243451 | Withdrawn | |
| 243449 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 1,801 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,310 |
| Diagnostix™ | American Diagnostic Corp. | 681 |
| Orantech | Orantech Inc. | 648 |
| Blood Pressure Cuff | Salter Labs | 425 |
| Aneroids (82 etc.) | Rashman Corp. | 418 |
| Medline | Medline Industries, Inc. | 390 |
| Baum | W.A. Baum Co., Inc. | 349 |
| Adcuff™ | American Diagnostic Corp. | 348 |
| Disposable cuff | Suntech Medical, Inc. | 326 |
| Vistarmed | Shenzhen Vistar Medical Supplies Co., Ltd. | 254 |
| Statcorp Medical | Statcorp, Inc. | 229 |
Showing 12 of 598. All products under Blood Pressure Cuff
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.