CHINA SURGICAL DRESSINGS CENTER CO.,LTD

FDA Device Registration & Listing · CHANGHWA CITY, FU-TIEN LI Changhua, TW · Registration 9613778

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
9613778
FEI Number
3002806752
Entity Name
CHINA SURGICAL DRESSINGS CENTER CO.,LTD
City/State/Country
CHANGHWA CITY, FU-TIEN LI Changhua, TW
Establishment Address
No. 21 Lane 424, Sec. 6 Chang Nan Rd., CHANGHWA CITY, FU-TIEN LI Changhua 50080, TW
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device
Owner / Operator
CHINA SURGICAL DRESSINGS CENTER CO.,LTD (Owner Number: 9014393)
Owner / Operator Contact Address
NO.21, LANE 424, SEC. 6, CHANGNAN ROAD, FU-TIEN LI, CHANGHUA CITY, TW-CHA 50080, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CSD CSD CSD CSD CSD CSD

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2007-11-27
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2015-01-27
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2023-02-06
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 2020-10-12
MHW Dressing, Compression General Hospital Class 1 880.5075 2016-02-02
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 1999-04-29
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 1999-04-29
FQM Bandage, Elastic General Hospital Class 1 880.5075 1999-04-29

Official Correspondent

MICHAEL F.L. CHANG

US Agent Details

Po Hung Chiang Business: CSD US Email: pochiang99@gmail.com Phone: (781) 8205651

Related Public Records

Same Entity

CHINA SURGICAL DRESSINGS CENTER 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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
K790050 Stanford Professional Products SPONGES, STANFORD STERILE LAP 1979-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613778. Last updated year: 2026. Please use registration number 9613778 when referencing this establishment in official correspondence.
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