Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBeijing Bohai Kangyuan Medical Devices Co., Ltd.
US
Last updated May 23, 2026
What Beijing Bohai Kangyuan Medical Devices Co., Ltd. makes
The company manufactures single-use and reusable surgical scalpels, including handles and blades, as well as adhesive bandages and leg procedure positioners. Their product line includes multiple variants of the comknife®, designed for surgical cutting applications, alongside medical adhesives and patient positioning aids.
All listed devices fall under Class I regulatory classification, with authorisation through the FDA’s Unique Device Identifier (UDI) system. The company’s products are registered under U.S. regulatory frameworks, ensuring compliance with medical device standards in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Beijing Bohai Kangyuan Medical Devices Co., Ltd. manufacture?
The company produces a range of surgical and wound care devices, including single-use and reusable scalpels (such as the comknife® series), reusable scalpel handles, adhesive bandages, and leg procedure positioners. These products are designed for use in surgical and procedural settings, covering cutting tools, adhesives, and patient positioning aids.
Where is Beijing Bohai Kangyuan Medical Devices Co., Ltd. based, and which regulatory registries list its devices?
The company is based in the United States. Its devices are listed in the FDA’s Unique Device Identifier (UDI) system, which is a key registry for tracking and identifying medical devices under U.S. regulatory requirements. This ensures compliance with U.S. medical device standards.
How are the devices manufactured by Beijing Bohai Kangyuan Medical Devices Co., Ltd. classified under U.S. regulations?
All devices produced by the company fall under Class I regulatory classification in the U.S. This classification applies to low-risk devices that pose minimal potential harm to patients, such as scalpels, handles, bandages, and positioners. Class I devices typically require compliance with general controls and, in this case, registration via the FDA’s UDI system.
What is the purpose of the comknife® product line, and how does it fit into the company’s offerings?
The comknife® series represents the company’s core line of surgical scalpels, available in multiple variants for single-use applications. These devices are designed for precise cutting in surgical procedures, complementing the company’s broader portfolio, which also includes reusable scalpel handles, adhesives, and patient positioning tools. The repeated listing of comknife® variants reflects its central role in their product line.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 552747785
Catalogue (305)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| comknife® | JPD-SD-L-298 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-420 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-611 | FDA UDI | Class I | Active |
| comknife® | JPD-SD-L-213 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-L-730 | FDA UDI | Class I | Active |
| comknife® | JPD-HQ-Z-40 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-L-270 | FDA UDI | Class I | Active |
| comknife® | JPD-CC-L-224 | EUDAMEDFDA UDI | Class I | Active |
| comknife® | JPD-QG-Z-341 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-L-723 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-605 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-L-717 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-L-727 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-L-724 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-463 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-Z-613 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-443 | FDA UDI | Class I | Active |
| comknife® | JPD-CZ-L-292 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-L-273 | FDA UDI | Class I | Active |
| comknife® | JPD-BL-B-2 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-L-277 | FDA UDI | Class I | Active |
| comknife® | JPD-CC-P-229 | FDA UDI | Class I | Active |
| comknife® | JPD-CC-L-235 | EUDAMEDFDA UDI | Class I | Active |
| comknife® | JPD-DT-W-601 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-432 | FDA UDI | Class I | Active |
| comknife® | JPD-CC-L-244 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-441 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-L-731 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-L-703 | FDA UDI | Class I | Active |
| comknife® | JPD-MC-L-257 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-401 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-451 | FDA UDI | Class I | Active |
| comknife® | JPD-MC-L-245 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-L-283 | FDA UDI | Class I | Active |
| comknife® | JPD-CC-P-237 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-Z-619 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-459 | FDA UDI | Class I | Active |
| comknife® | JPD-SD-L-296 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-Z-342 | FDA UDI | Class I | Active |
| comknife® | JPD-CZ-L-294 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-431 | FDA UDI | Class I | Active |
| comknife® | JPD-DT-Z-356 | EUDAMEDFDA UDI | Class I | Active |
| comknife® | JPD-QG-W-460 | FDA UDI | Class I | Active |
| comknife® | JPD-QG-W-465 | FDA UDI | Class I | Active |
| comknife® | JPD-KQ-L-279 | FDA UDI | Class I | Active |
| comknife® | JPD-CC-L-232 | FDA UDI | Class I | Active |
| comknife® | JPD-BL-B-3 | FDA UDI | Class I | Active |
| comknife® | JPD-HQ-Z-50 | FDA UDI | Class I | Active |
| comknife® | JPD-HX-Z-50 | FDA UDI | Class I | Active |
| comknife® | JPD-KQ-L-281 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Beijing Bohaikangyuan Medical Devices Co., Ltd. Beijing Economic and Technological Development Area · CN FEI 3030017472