BIO Protech Yantai Inc
Registered establishment in Yantai, Shandong, China. 12 device types.
BIO Protech Yantai Inc is a manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Electrode, Needle and 10 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | BIO PROTECH YANTAI INC |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010805941 |
| FEI number | 3010805941 |
| Establishment type | Manufacturer |
Location
| City | Yantai |
|---|---|
| Province | Shandong |
| Address | 50 – 9, Beijingzhong Road |
| Postal code | 264000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Exhaust, Surgical | Class 2 | EvaQMax | 2019 | 3 |
| Cable, Electrode | Class 2 | Cable, Electrode | 2011 | 47 |
| Electrode, Cutaneous | Class 2 | Proemg, Proeeg, Protens, Soft-Touch™ | 2007 | 47 |
| Electrode, Electrocardiograph | Class 2 | Telectrode, Protab, Proneo | 2007 | 33 |
| Electrode, Needle | Class 2 | Proemg | 2016 | 4 |
| Electrode, Needle, Diagnostic Electromyograph | Class 2 | Proemg | 2016 | 2 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Propencil, Proplate | 2007 | 65 |
| Interferential Current Therapy | Class 2 | Maxif | 2010 | 7 |
| Stimulator, Muscle, Powered | Class 2 | Maxems | 2009 | 33 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Ultima5, Maxtens | 2008 | 32 |
| Tubing, Noninvasive | Class 2 | Smoke Evacuation Tubing, EvaQMax Laparo | 2024 | 33 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | Class 1 | EvaQMax Laparo | 2020 | 12 |
Clearances
No clearance names BIO Protech Yantai Inc as applicant. 19 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K192035 | 2019-08-29 | FYD | Traditional | BIO Protech, Inc. |
| K152984 | 2016-06-03 | IKT | Traditional | BIO Protech, Inc. |
| K153019 | 2016-03-21 | GXY | Traditional | BIO Protech, Inc. |
| K143103 | 2015-07-16 | GEI | Traditional | BIO Protech, Inc. |
| K142099 | 2014-11-17 | GXY | Traditional | BIO Protech, Inc. |
| K111270 | 2011-09-13 | GXY | Traditional | BIO Protech, Inc. |
| K100246 | 2010-11-24 | LIH | Traditional | BIO Protech, Inc. |
| K091248 | 2009-11-30 | IPF | Traditional | BIO Protech, Inc. |
| K092732 | 2009-11-25 | GEI | Traditional | BIO Protech, Inc. |
| K092761 | 2009-11-24 | GEI | Special | BIO Protech, Inc. |
| K083494 | 2009-01-06 | GZJ | Traditional | Pain Management Technologies |
| K083148 | 2008-11-07 | DRX | Traditional | BIO Protech, Inc. |
| K073438 | 2008-02-07 | GZJ | Traditional | BIO Protech, Inc. |
| K073360 | 2007-12-19 | GEI | Traditional | BIO Protech, Inc. |
| K053011 | 2005-12-14 | DRX | Traditional | BIO Protech, Inc. |
| K042301 | 2004-09-03 | GXY | Traditional | BIO Protech, Inc. |
| K040784 | 2004-04-07 | DRX | Traditional | BIO Protech, Inc. |
| K030375 | 2003-05-05 | GXY | Traditional | Pain Management Technologies |
| K020003 | 2002-11-07 | DRX | Traditional | BIO Protech, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Main products | ECG electrodes, TENS electrodes, Medical electrodes |
| Export markets | USA, Pakistan, Philippines |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shandong Jinlai Huanhai Medical Technology Co., Ltd. | 19 |
| B&E BIO-Technology Co., Ltd. | 9 |
| Yantai Addcare Bio-Tech Co., Ltd. | 8 |
| HBH Biotechnology Limited | 6 |
| Yantai Yulong Commodity Co., Ltd. | 5 |
| Yantai Bagmart Packaging Co Ltd | 3 |
| Yantai Atomy DEO Tech Daily-USE Commodity Co., Ltd. | 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.
The manufacturer named here can complete this record.