Soft-CUF
Soft-CUF, Large Adult, 1 TB Bayonet, 31 - 40 CM, International, Single
50manufacturers in China registered for this device type
102catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | DXQ |
| Device type | Blood Pressure Cuff |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1120 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K120125 |
| Record published | 2016-06-30 |
| Record revised | 2026-01-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -20 to 55 °C; Storage environment humidity 15 to 95 % RH |
| Packaging | Pack of 20 |
| Distribution end date | 2025-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2365 | Thigh | In distribution |
| 2121 | NEONATAL1 | In distribution |
| 2125 | NEONATAL4 | In distribution |
| 2360 | Infant | In distribution |
| SFT-P2-2A | Child | In distribution |
| 2361 | Child | In distribution |
| 2363-INT | Adult | In distribution |
| SFT-N4-2B | NEONATAL4 | In distribution |
| 2521 | NEONATAL1 | In distribution |
| 2524 | NEONATAL4 | In distribution |
| SFT-P2-2A-L | Child Long | In distribution |
| SFT-A2-2A | Adult | In distribution |
| SFT-N5-1B | NEONATAL5 | In distribution |
| 2422 | NEONATAL2 | In distribution |
| SFT-N1-1B | NEONATAL1 | In distribution |
| SFT-A1-2A-L | Small Adult Long | In distribution |
| 2126 | NEONATAL5 | In distribution |
| 2525 | NEONATAL5 | In distribution |
| 2122 | NEONATAL2 | In distribution |
| SFT-N4-1B | NEONATAL4 | In distribution |
| SFT-N2-1B | NEONATAL2 | In distribution |
| SFT-N2-2B | NEONATAL2 | In distribution |
| SFT-A2-2A-L | Adult Long | In distribution |
| SFT-N5-2B | NEONATAL5 | In distribution |
| 2141 | Large Adult Long | In distribution |
| SFT-A3-2A-L | Large Adult Long | In distribution |
| SFT-P1-2A | Infant | In distribution |
| SFT-N1-2B | NEONATAL1 | In distribution |
| 2140 | Adult Long | In distribution |
| 2362 | Small Adult | In distribution |
| SFT-A1-2A-INT | Small Adult | In distribution |
| SFT-N3-1B | NEONATAL3 | In distribution |
| SFT-N3-2B | NEONATAL3 | In distribution |
| 2140-INT | Adult Long | In distribution |
| SFT-F1-2A | Forearm | In distribution |
| SFT-T1-2A | Thigh | In distribution |
| SFT-A1-2A | Small Adult | In distribution |
| 2364-INT | Large Adult | In distribution |
| SFT-P2-2A-INT | Child | In distribution |
| SFT-A2-2A-INT | Adult | In distribution |
| SFT-A3-2A-INT | Large Adult | In distribution |
| SFT-A2-2A-L-INT | Adult Long | In distribution |
| 2124 | NEONATAL3 | In distribution |
| 2523 | NEONATAL3 | In distribution |
| 2363 | Adult | Withdrawn |
| 002332 | Child | Withdrawn |
| 2320 | Infant | Withdrawn |
| 2453 | Adult | Withdrawn |
| SFT-F1-2C | Forearm | Withdrawn |
| 2405-INT | Large Adult | Withdrawn |
| 2505 | Thigh | Withdrawn |
| 002336 | Adult Long | Withdrawn |
| 2400 | Child Long | Withdrawn |
| 2407 | Small Adult Long | Withdrawn |
| 2604 | Adult Long | Withdrawn |
| 2321 | Child | Withdrawn |
| 2116-INT | Adult Long | Withdrawn |
| 2503-INT | Adult | Withdrawn |
| 002337 | Large Adult | Withdrawn |
| 2503 | Adult | Withdrawn |
| 2504 | Large Adult | Withdrawn |
| 2454 | Adult Long | Withdrawn |
| 2455 | Large Adult | Withdrawn |
| 2451 | Child | Withdrawn |
| 2406 | Thigh | Withdrawn |
| 2401 | Infant | Withdrawn |
| 2402 | Child | Withdrawn |
| SFT-A3-2A | Large Adult | Withdrawn |
| 2644 | Large Adult Long | Withdrawn |
| 2364 | Large Adult | Withdrawn |
| 2502 | Small Adult | Withdrawn |
| 002331 | Infant | Withdrawn |
| 2502-INT | Small Adult | Withdrawn |
| 2322 | Small Adult | Withdrawn |
| 2457 | Thigh | Withdrawn |
| 2403-INT | Small Adult | Withdrawn |
| 2452 | Small Adult | Withdrawn |
| 2450 | Infant | Withdrawn |
| 2500 | Infant | Withdrawn |
| 2325 | Thigh | Withdrawn |
| 002335 | Adult | Withdrawn |
| 2404-INT | Adult | Withdrawn |
| 2507 | Small Adult Long | Withdrawn |
| 2403 | Small Adult | Withdrawn |
| 002333 | Small Adult | Withdrawn |
| 2506 | Child Long | Withdrawn |
| 2501 | Child | Withdrawn |
| 2116 | Adult Long | Withdrawn |
| 2404 | Adult | Withdrawn |
| 2324 | Large Adult | Withdrawn |
| 2117 | Adult Long | Withdrawn |
| 2504-INT | Large Adult | Withdrawn |
| 2405 | Large Adult | Withdrawn |
| 2456 | Large Adult Long | Withdrawn |
| SFT-F1-2E | Withdrawn | |
| SFT-F1-2D | Forearm | Withdrawn |
| 2323 | Adult | Withdrawn |
| 002339 | Thigh | Withdrawn |
| 2604-INT | Adult Long | Withdrawn |
| 2362-INT | Small Adult | Withdrawn |
| 002334 | Small Adult Long | Withdrawn |
| 002338 | Large Adult Long | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230145 | 2023-03-14 |
| K123996 | 2013-04-09 |
| K120125 | 2012-10-03 |
| K022482 | 2002-08-13 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-04-09 | Class II | Under Investigation by firm | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | 23,180/20-cuff boxes |
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.