FDA Registration
Active
🇨🇳 China
BEIJING ZKSK TECHNOLOGY CO., LTD.
Reg #: 3014620201
·
FEI: 3014620201
·
Expires 2026
Products
38
Proprietary Names
41
Establishment Types
2
Classifications
38
Registration Details
- Registration Name
- BEIJING ZKSK TECHNOLOGY CO., LTD.
- Registration Number
- 3014620201
- FEI Number
- 3014620201
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Economic Development Zone, Tongzhou District
- City
- beijing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213217
Owner / Operator
- Firm Name
- Beijing ZKSK Technology Co., Ltd.
- Operator Number
- 10064072
- Address
- Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Economic Development Zone, Tongzhou District
- City
- Beijing
- State
- CN-BJ
- Postal Code
- 101105
- Country
- CN
- Correspondent
- LI MA
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- hui hong
- Address
- 800 East Wishkah Street, 1021 Aberdeen,
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2025-05-07 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-04-13 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2023-12-20 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-23 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2023-01-09 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-03 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-03-23 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2020-03-23 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2020-12-24 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-03-23 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2020-03-23 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2020-03-23 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2020-03-23 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2023-12-22 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2020-03-23 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2020-03-23 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2024-12-23 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2020-03-23 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-23 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2020-12-24 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2020-03-23 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2022-06-08 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2020-03-23 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2025-02-10 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2020-12-24 |
| Ligator, Esophageal | MND | Class 2 | Gastroenterology, Urology | No | 2023-12-20 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2022-06-08 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-12-24 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2022-06-08 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2020-03-23 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2020-03-23 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2020-03-23 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2020-03-23 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
Proprietary Names
Disposable Bone Cement Vacuum Mixing System: ZKVMS18T, ZKVMS18W
CPE Gown
Disposable Endoscopic Guidewire
Disposable Surgical Mask, Face Mask, Disposable Nonwoven Face Mask
Disposable Medical Face Mask, Disposable 3-layers Surgical Mask, Disposable Surgical Mask
Nonpneumatic Tourniquet
Disposable Exsanguination Tourniquet
Disposable hemoclip
Disposable Face Mask
Absorbent Cotton, Absorbent Cotton Ball
Dental Instrument Kit
Disposable Biopsy Forceps-BF18-B18/120P; BF18-G23/160P; BF18-G23/180P; BF18-E23/230P; BF18-C23/50P
Disposable Biopsy Forceps
Medical Isolation Goggles, Safety Glasses, Goggles, Medical Face Shield, Face Shield
Disposable Isolation Gown
Absorbent Cotton, Absorbent Cotton Ball, Medical Cotton Swabs
Tongue Depressors
Splint
Disposable Endoscopic Retrieval Net
Disposable Stone Extraction Basket
Dental Instrument Forceps
Dental Tweezers
Disposable Hot Biopsy Forceps
The Mouth Mirror
N95 Particulate Respirators Masks, N95 Face Mask, KN95 Dust Mask, KN95 Face Mask, Face Mask With Face Shield
Disposable Shoes Cover
Disposable Pulse Lavage-EP18-01; EP18-02; EP18-03; EP18-04; EP18-05; EP18-06; EP18-07; EP18-08; EP18-09; EP18-10
Disposable Pulse Lavage-EP18-11; EP18-12; EP18-13; EP18-14; EP18-18-15; EP18-16; EP18-17; EP18-18; EP18-19; EP18-20
First Aid Kit With Drug
Endoscopic Injection Needle
Ice Pack
Disposable Sphincterotome
Salivary Duct
Multi-Band Ligator
Disposable Ligation Device
Disposable Polypectomy Snare
Hood-18A-800; 18A-800P
Dental Probe
Mercury Thermometer, Thermometer
Gauze Bandage, Stockinette Bandage, Mesh Bandage,Triangular Bandage, Wound Plaster, Gauze Pad
Disposable Protective Clothing, CPE Gown
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)