Fukuda Denshi
41 catalogue numbers from TE-43, listed by Fukuda Denshi Co., Ltd., Japan, under Electrocardiograph. 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph
Record
| Listed by | Fukuda Denshi Co., Ltd., Japan |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K971440 |
| Record published | 2022-10-24 |
| Record revised | 2021-03-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TE-43 | In distribution | |
| OP210-02TGUFLS | In distribution | |
| BTE-002 | In distribution | |
| TE-01 | In distribution | |
| FP-908A | In distribution | |
| CJS-03DA5-C | In distribution | |
| OAE-65A | In distribution | |
| CIE-01B | In distribution | |
| FX-7102 | In distribution | |
| HPU15-102-W/UL | In distribution | |
| OAE-61A | In distribution | |
| OAE-53A | In distribution | |
| OAE-50A | In distribution | |
| OTE-10 | In distribution | |
| OAE-47A | In distribution | |
| OAO-1008A | In distribution | |
| FP-811 | In distribution | |
| CP-202L-2037 | In distribution | |
| OAE-52A | In distribution | |
| EE-50 | In distribution | |
| TE-43 | In distribution | |
| FP-908LP | In distribution | |
| CME-03FTAA | In distribution | |
| CME-77FJK-W | In distribution | |
| FX-9800 | In distribution | |
| CJ-325 | In distribution | |
| FCP-7101 | In distribution | |
| TE-01 | In distribution | |
| CME-77FJKA | In distribution | |
| EE-51 | In distribution | |
| CPE-01AKPA-2038 | In distribution | |
| FX-8400 | In distribution | |
| OAO-1007A | In distribution | |
| OAE-57A | In distribution | |
| FX-7202 | In distribution | |
| BTE-004 | In distribution | |
| OAE-63A | In distribution | |
| CE-11 | In distribution | |
| CP-105L-2038 | In distribution | |
| OAE-58A | In distribution | |
| OAE-51A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| ELI 380 | Mortara Instrument, Inc. | 69 |
| Patient Cable Lead Set | Mortara Instrument, Inc. | 56 |
| ELI 250c | Mortara Instrument, Inc. | 50 |
| Lutech | Lutech Industries | 49 |
| ELI 150c | Mortara Instrument, Inc. | 47 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| XScribe | Mortara Instrument, Inc. | 22 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 21 |
Showing 12 of 177. All products under Electrocardiograph
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.