Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006538822

FEI Number

3006538822

Entity Name

SUZHOU ACMED IMPORT & EXPORT CO., LTD.

City/State/Country

SUZHOU Jiangsu, CN

Establishment Address

436 Changjiang Road, 2-10016, SUZHOU Jiangsu 215011, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SUZHOU ACMED IMPORT & EXPORT CO., LTD. (Owner Number: 10025772)

Owner / Operator Contact Address

436 Changjiang Road,, 2-10016, SUZHOU, CN-JS 215011, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Triangular Bandage BORDER GAUZE SPONGES; COTTON; NON-WOVEN VAGINAL SPECULUMS BEDDING, DISPOSABLE, MEDICAL TUBING, NONINVASIVE ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE GAUZE; LAP AND VAGINAL SPONGES DISPOSABLE FACE MASK Sterile hydrocolloid dressing Enteral Delivery Pump Bag Set Enteral Feeding Gravity Bag Set Enteral Delivery Pump Set; Enteral Delivery Pump Bag Set;Enteral Feeding Gravity Bag Set Enteral Delivery Pump Set SURGICAL GOWNS APPLICATOR, ABSORBENT TIPPED, NON-STERILE SHOE COVER, TERRY TREADS; SLIPPER S BASIN, EMESIS SURGICAL TOWEL COTTON; STOCKINETTE Umbilical Cord Clamp Cutter CATHETER, CONTINUOUS IRRIGATION SURGICAL DRAPE BULB; EAR SYRINGE; IRRIGATION TOWEL CLAMP FORCEPS SHEETS-DRAPES; STAND & EQUIPMENT COVERS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-08-05
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2018-01-04
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2008-05-07
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2017-05-20
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2008-05-07
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2011-05-17
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2015-12-19
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2008-05-07
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2010-01-12
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-05-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-01-17
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2009-11-03
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-01-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2010-01-13
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2023-12-06
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2008-05-07
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2008-05-07
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2017-02-21
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2008-05-07
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2009-11-03
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2008-05-07
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-05-07
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-05-07
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2008-05-07

Official Correspondent

Mark Ho

US Agent Details

Anna Sun Business: Sun Luna Star LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

SUZHOU ACMED IMPORT & EXPORT 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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006538822. Last updated year: 2026. Please use registration number 3006538822 when referencing this establishment in official correspondence.