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Sign in to claim this brandBeijing ZKSK Technology Co., Ltd
China·CN-MF-000010403
Last updated May 27, 2026
What Beijing ZKSK Technology Co., Ltd makes
Beijing ZKSK Technology Co., Ltd manufactures single-use endoscopic tools, including general-purpose biopsy needles, polypectomy ligators, and gastrointestinal clips designed for short-term use. Their portfolio also includes reusable soft-tissue biopsy kits, disposable irrigation/aspiration systems, and manual limb tourniquets. Additional products encompass oesophageal ligators and guidewires for gastro-urological procedures.
The company’s devices are classified under EU regulations as Class I, Class II, and Class IIb, with listings in the EUDAMED registry, FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in China.
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 ZKSK Technology Co., Ltd primarily manufacture?
Beijing ZKSK Technology Co., Ltd specializes in single-use and reusable endoscopic devices. Their portfolio includes general-purpose endoscopic needles for biopsies, polypectomy ligators for removing polyps, gastrointestinal clips for short-term use, and gastro-urological guidewires. They also produce disposable surgical irrigation/aspiration systems, manual limb tourniquets, and oesophageal ligators. These tools are designed for minimally invasive procedures in endoscopy and surgical settings.
Where is Beijing ZKSK Technology Co., Ltd based, and how does this affect their device listings?
The company is based in China. Due to its global operations, its devices are listed in multiple regulatory databases, including the EUDAMED registry for EU compliance, the FDA’s 510(k) clearance database for US pre-market notifications, and the FDA’s Unique Device Identifier (UDI) system. This reflects their focus on international markets and adherence to regulatory requirements in both regions.
How are the devices manufactured by Beijing ZKSK Technology Co., Ltd classified under EU regulations?
Under EU regulations, the devices produced by Beijing ZKSK Technology Co., Ltd fall into different risk-based classifications: Class I for low-risk items like some single-use tools, Class II for moderate-risk devices such as biopsy kits and irrigation systems, and Class IIb for higher-risk items like polypectomy ligators and endoscopic clips. The classification determines the regulatory scrutiny and conformity assessment procedures required for market authorization.
Which regulatory registries list devices from Beijing ZKSK Technology Co., Ltd?
Devices from Beijing ZKSK Technology Co., Ltd are listed in key global regulatory databases, including the EUDAMED registry for transparency in the European Union, the FDA’s 510(k) database for pre-market clearance notifications in the United States, and the FDA’s Unique Device Identifier (UDI) system. These listings help ensure traceability and compliance with regulatory requirements in both markets.
Why do some devices from Beijing ZKSK Technology Co., Ltd fall under Class IIb classification?
Class IIb classification in the EU applies to devices that pose a higher risk to patient safety due to their intended use or potential complications. For example, polypectomy ligators and endoscopic clips are classified as Class IIb because they are used in critical procedures like polyp removal or tissue approximation, where improper use could lead to severe outcomes such as perforation or hemorrhage. This classification requires stricter manufacturing controls and clinical evaluations to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- Building 9, 6 & No.6, Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzhou District,, Beijing City, China
- Website
- 163.com
- —
- —
- [email protected]
- Phone
- +86 13269337708
- PRRC Contact
- Siyuan Cheng
- EUDAMED SRN
- CN-MF-000010403
- FDA FEI Number
- —
- DUNS Number
- 542947117
Catalogue (349)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zksk | BF18-F18/180P-J | FDA UDI | Class I | Active |
| Zksk | SN19-07/160-6 | FDA UDI | Class II | Active |
| Zksk | HC-16-230/26 | FDA UDI | Class II | Active |
| Zksk | SN18-09/195-8 | FDA UDI | Class II | Active |
| Zksk | EP18-08 | FDA UDI | Class II | Active |
| Zksk | BF18-F18/230P-J | FDA UDI | Class I | Active |
| Zksk | BF18-A23/160 | FDA UDI | Class I | Active |
| Zksk | GW18-35-200 | FDA UDI | Class II | Active |
| Zksk | BF18-F18/180-J | FDA UDI | Class I | Active |
| Zksk | SN18-05/160-10 | FDA UDI | Class II | Active |
| Zksk | BF18-A18/230P | FDA UDI | Class I | Active |
| Zksk | SN18-09/200-8 | FDA UDI | Class II | Active |
| Zksk | EP18-12 | FDA UDI | Class II | Active |
| Zksk | BF18-A23/120 | FDA UDI | Class I | Active |
| Zksk | SN18-09/200-4 | FDA UDI | Class II | Active |
| Zksk | HC-12-195/26P | FDA UDI | Class II | Active |
| Zksk | SN18-07/160-8 | FDA UDI | Class II | Active |
| Zksk | EP18-13 | FDA UDI | Class II | Active |
| Zksk | SN18-05/230-10 | FDA UDI | Class II | Active |
| Zksk | GW18-32-450 | FDA UDI | Class II | Active |
| Zksk | HF18-A24/120 | FDA UDI | Class II | Active |
| Zksk | HC-12-230/26P | FDA UDI | Class II | Active |
| Zksk | HC-8-230/26P | FDA UDI | Class II | Active |
| Zksk | ECH 18-040-190 | FDA UDI | Class I | Active |
| Zksk | BF18-A18/180P | FDA UDI | Class I | Active |
| Zksk | SN18-07/160-4 | FDA UDI | Class II | Active |
| Zksk | SN19-07/200 | FDA UDI | Class II | Active |
| Zksk | BL18-8A | FDA UDI | Class II | Active |
| Zksk | BL18-6A | FDA UDI | Class II | Active |
| Zksk | SN19-05/195-6 | FDA UDI | Class II | Active |
| Zksk | SN18-05/160-8 | FDA UDI | Class II | Active |
| Zksk | HE15-195-1 | FDA UDI | Class II | Active |
| Zksk | BL18-4A | FDA UDI | Class II | Active |
| Zksk | HC-12-165/26 | FDA UDI | Class II | Active |
| Zksk | BF18-A18/160 | FDA UDI | Class I | Active |
| Zksk | SN19-05/195-4 | FDA UDI | Class II | Active |
| Zksk | HE20-165-1 | FDA UDI | Class II | Active |
| Zksk | BF18-F23/230-J | FDA UDI | Class I | Active |
| Zksk | SN18-09/160-10 | FDA UDI | Class II | Active |
| Zksk | BL18-8M | FDA UDI | Class II | Active |
| Zksk | HC-8-230/26 | FDA UDI | Class II | Active |
| Zksk | BF18-A23/160P | FDA UDI | Class I | Active |
| Zksk | BF18-F18/50P-J | FDA UDI | Class I | Active |
| Zksk | HE15-230-3 | FDA UDI | Class II | Active |
| Zksk | SN18-09/230-4 | FDA UDI | Class II | Active |
| Zksk | SN18-07/230-6 | FDA UDI | Class II | Active |
| Zksk | BL18-4M | FDA UDI | Class II | Active |
| Zksk | HC-12-165/26P | FDA UDI | Class II | Active |
| Zksk | SN18-09/200-10 | FDA UDI | Class II | Active |
| Zksk | SN19-05/160 | FDA UDI | Class II | Active |
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