CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO.,LTD

FDA Device Registration & Listing · Changzhou Jiangsu, CN · Registration 3012922212

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
3012922212
FEI Number
3012922212
Entity Name
CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO.,LTD
City/State/Country
Changzhou Jiangsu, CN
Establishment Address
No. 57 Limao Road, Lijia Town, Wujin District, Changzhou Jiangsu 213000, CN
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Changzhou Shengkang Medical Instrument Co.,LTD (Owner Number: 10095334)
Owner / Operator Contact Address
No. 57 Limao Road, Lijia Town, Wujin District, Changzhou, CN-JS 213000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Dental tray Disposable dental irrigation needles Disposable dental cotton rolls Disposable dental mirror Disposable dental saliva ejector Micro applicator Polishing brush

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2026-02-27
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2026-02-27
EFN Cotton, Roll Dental Class 1 872.6050 2026-02-27
EIX Probe, Periodontic Dental Class 1 872.4565 2026-02-27
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2026-02-27
NXB Dispenser, Solid Medication Physical Medicine Class 1 890.5050 2026-02-27
EHK Cup, Prophylaxis Dental Class 1 872.6290 2026-02-27

Official Correspondent

NANPING WANG

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Changzhou Shengkang Medical Instrument 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
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04
K944481 Garan Scientific, Inc. THE HEART PROTECTOR 1995-04-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012922212. Last updated year: 2026. Please use registration number 3012922212 when referencing this establishment in official correspondence.
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