Beijing Zksk Technology Co., Ltd.
Manufacturer and brand owner in Beijing, China. 38 device types, 14 products catalogued, 6 clearances.
Beijing Zksk Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Lavage, Jet and 36 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
38device types registered with the FDA
14products catalogued under its own name
6510(k) clearances
Registration
| Registered name | BEIJING ZKSK TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014620201 |
| FEI number | 3014620201 |
| DUNS | 542947117 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 北京中科盛康科技股份有限公司 |
|---|---|
| Unified social credit code | 91110106684397431L |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Economic Development Zone, Tongzhou District |
| Postal code | 101105 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | Class 1 | Absorbent Cotton, Absorbent Cotton Ball | 2020 | 100 |
| Bag, Ice | Class 1 | Ice Pack | 2020 | 86 |
| Bandage, Elastic | Class 1 | Gauze Bandage, Stockinette Bandage, Mesh Bandage,Triangular Bandage, Wound Plaster, Gauze Pad | 2020 | 280 |
| Cap, Surgical | Class 1 | Hood-18A-800; 18A-800P | 2020 | 178 |
| Clip, Implantable | Class 2 | Multi-Band Ligator | 2020 | 4 |
| Cotton, Roll | Class 1 | Absorbent Cotton, Absorbent Cotton Ball, Medical Cotton Swabs | 2020 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Disposable Shoes Cover | 2020 | 176 |
| Depressor, Metal Tongue, Surgical | Class 1 | Tongue Depressors | 2020 | 10 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue Depressors | 2020 | 100 |
| Dilator, Catheter | Class 1 | Salivary Duct | 2020 | 7 |
| Dress, Surgical | Class 1 | Disposable Protective Clothing, CPE Gown | 2020 | 71 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Disposable Stone Extraction Basket, Disposable Endoscopic Retrieval Net | 2023 | 21 |
| Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | Disposable Endoscopic Guidewire | 2023 | 21 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Endoscopic Injection Needle | 2022 | 23 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Disposable Face Mask | 2020 | 182 |
| First Aid Kit With Drug | Class N | First Aid Kit With Drug | 2020 | 57 |
| Forceps, Biopsy, Electric | Class 2 | Disposable Hot Biopsy Forceps | 2024 | 3 |
| Forceps, Biopsy, Non-Electric | Class 1 | Disposable Biopsy Forceps-BF18-B18/120P; BF18-G23/160P; BF18-G23/180P; BF18-E23/230P; BF18-C23/50P, Disposable Biopsy Forceps | 2020 | 44 |
| Forceps, Dressing, Dental | Class 1 | Dental Tweezers | 2020 | 22 |
| Forceps, Tooth Extractor, Surgical | Class 1 | Dental Instrument Forceps | 2020 | 20 |
| Hemostatic Metal Clip For The Gi Tract | Class 2 | Disposable hemoclip | 2023 | 17 |
| Instruments, Dental Hand | Class 1 | Dental Instrument Kit | 2020 | 64 |
| Lavage, Jet | Class 2 | Disposable Pulse Lavage-EP18-11; EP18-12; EP18-13; EP18-14; EP18-18-15; EP18-16; EP18-17; EP18-18; EP18-19; EP18-20, Disposable Pulse Lavage-EP18-01; EP18-02; EP18-03; EP18-04; EP18-05; EP18-06; EP18-07; EP18-08; EP18-09; EP18-10 | 2020 | 17 |
| Ligator, Esophageal | Class 2 | Multi-Band Ligator, Disposable Ligation Device | 2022 | 7 |
| Ligator, Hemorrhoidal | Class 2 | Multi-Band Ligator | 2022 | 12 |
| Mask, Scavenging | Class 1 | Disposable Medical Face Mask, Disposable 3-layers Surgical Mask, Disposable Surgical Mask, Disposable Surgical Mask, Face Mask, Disposable Nonwoven Face Mask | 2020 | 158 |
| Mirror, Mouth | Class 1 | The Mouth Mirror | 2020 | 94 |
| Mixer, Cement, For Clinical Use | Class 1 | Disposable Bone Cement Vacuum Mixing System: ZKVMS18 → T, ZKVMS18 → W | 2025 | 14 |
| Non-Surgical Gown | Class 1 | Disposable Isolation Gown | 2020 | 318 |
| Probe, Periodontic | Class 1 | Dental Probe | 2020 | 34 |
| Respirator, Surgical | Class 2 | N95 Particulate Respirators Masks, N95 Face Mask, KN95 Dust Mask, KN95 Face Mask, Face Mask With Face Shield | 2020 | 118 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Medical Isolation Goggles, Safety Glasses, Goggles, Medical Face Shield, Face Shield | 2020 | 384 |
| Snare, Flexible | Class 2 | Disposable Polypectomy Snare | 2022 | 7 |
| Splint, Hand, And Components | Class 1 | Splint | 2020 | 144 |
| Suit, Surgical | Class 1 | CPE Gown | 2020 | 74 |
| Thermometer, Clinical Color Change | Class 1 | Mercury Thermometer, Thermometer | 2020 | 15 |
| Tourniquet, Nonpneumatic | Class 1 | Nonpneumatic Tourniquet, Disposable Exsanguination Tourniquet | 2020 | 124 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class 2 | Disposable Sphincterotome | 2025 | 7 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242192 | 2025-02-06 | KNS | Traditional | This company |
| K231721 | 2023-12-14 | KGE | Traditional | This company |
| K213217 | 2022-11-14 | PKL | Traditional | This company |
| K213222 | 2022-06-06 | FDI | Traditional | This company |
| K213223 | 2022-06-06 | FHN | Traditional | This company |
| K213239 | 2022-06-02 | FBK | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Factory area | 3,000 sq meters |
| Main products | Endoscopy consumables, Orthopedic consumables, Blood purification consumables, Weight reduction devices, Protective products |
| Certifications | FDA, EU CE, ISO 13485 |
| Export markets | 70 countries |
Nearby Manufacturers
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.