BEIJING ZKSK TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · beijing, CN · Registration 3014620201

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014620201
FEI Number
3014620201
Entity Name
BEIJING ZKSK TECHNOLOGY CO., LTD.
City/State/Country
beijing, CN
Establishment Address
Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Economic Development Zone, Tongzhou District, beijing 101105, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Beijing ZKSK Technology Co., Ltd. (Owner Number: 10064072)
Owner / Operator Contact Address
Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Economic Development Zone, Tongzhou District, Beijing, CN-BJ 101105, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213222
PMA Number
N/A

All Registered Proprietary Names

Disposable Bone Cement Vacuum Mixing System: ZKVMS18–T, ZKVMS18–W 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2025-05-07
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2020-04-13
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-12-20
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2020-03-23
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2020-03-23
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-01-09
QKR Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Unknown Class N N/A 2020-04-03
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2020-03-23
DZN Instruments, Dental Hand Dental Class 1 872.4565 2020-03-23
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2020-12-24
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2020-03-23
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-23
EFN Cotton, Roll Dental Class 1 872.6050 2020-03-23
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2020-03-23
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2020-03-23
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2023-12-22
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2020-03-23
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2020-03-23
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2024-12-23
EAX Mirror, Mouth Dental Class 1 872.4565 2020-03-23
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-23
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2020-03-23
FQH Lavage, Jet General Hospital Class 2 880.5475 2020-12-24
LRR First Aid Kit With Drug Unknown Class N N/A 2020-03-23
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2022-06-08
KYR Bag, Ice General Hospital Class 1 880.6050 2020-03-23
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2025-02-10
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2020-03-23
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2020-12-24
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2023-12-20
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2022-06-08

Official Correspondent

LI MA

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Beijing ZKSK Technology Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K102092 Prestige Ameritech PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES 2010-10-06
K213616 Becton, Dickinson and Company BD Surgiphor Antimicrobial Irrigation System 2022-03-23
K172288 Wilson-Cook Medical Inc./Cook Endoscopy Fusion OMNI Sphincterotome 2018-04-17
K200745 United States Endoscopy Group, Inc. Lariat, Hot/Cold Snare 2020-04-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014620201. Last updated year: 2026. Please use registration number 3014620201 when referencing this establishment in official correspondence.
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