SunMed
Double Adhesive Disk 100/ROLL
6manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| ADC Ningbo Co., Ltd. | Ningbo | Zhejiang | Exporter | 13 |
| MDF Instruments Medifriend Inc. | Song Jiang District | Shanghai | Repacker / relabeller | 13 |
| Ningbo Jiangbei Tenso Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 4 |
Record
| Listed by | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | BZS |
| Device type | Stethoscope Head |
| Device class | Class 1 |
| Regulation | 21 CFR 868.1930 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-01 |
| Record revised | 2024-11-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 0.875 to 1.44 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6-0027-41 | In distribution | |
| 6-0025-00 | Outer Diameter 0.875 in | In distribution |
| 6-1030-53 | In distribution | |
| 6-0025-01 | Outer Diameter 1.125 in | In distribution |
| 6-0025-02 | Outer Diameter 1.125 in | In distribution |
| 6-0025-05 | In distribution | |
| 6-0027-40 | In distribution | |
| 6-0027-42 | In distribution | |
| 6-0027-43 | In distribution | |
| 6-0025-03 | Outer Diameter 1.44 in | In distribution |
| 6-1030-52 | In distribution | |
| 6-0025-25 | In distribution | |
| 6-1030-50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adscope® | American Diagnostic Corp. | 83 |
| AincA® | Anesthesia Associates, Inc. | 17 |
| Adimals® | American Diagnostic Corp. | 5 |
| Proscope™ | American Diagnostic Corp. | 4 |
| Hopkins Medical Products® | Hopkins Uniform Company | 2 |
| Adscope® Vistascope™ | American Diagnostic Corp. | 1 |
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.