Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3041329419

FEI Number

3041329419

Entity Name

SYNTHETAH, LLC

City/State/Country

SHANGHAI, CN

Establishment Address

SUITE 901, NO.3255 ZHOUJIAZUI BLVD, SHANGHAI 200093, CN

Establishment Type(s)

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

Owner / Operator

SYNTHETAH, LLC (Owner Number: 10094836)

Owner / Operator Contact Address

SUITE 901, NO.3255 ZHOUJIAZUI BLVD, SHANGHAI, CN-NOTA 200093, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ADHESIVE REMOVER SPRAY DRESSING PAD COMBINED ABSORBENT, DRY WIPES, GAUZE SPONGE, GAUZE SWABS 100% COTTON, CONFORMING BANDAGE, ABSORBENT GAUZE ROLL 100% COTTON, BURN PAD, COTTON BALL, DENTAL ROLL 100% COTTON, DRESSING PACK FOR HEAVY DRAINAGE, FLUFFY GAUZE BANDAGE ROLL, FLUFFY GAUZE SPONGE OSTOMY BAG FOLEY CATHETER HOLDER SILICONE GEL SCAR DRESSING, SILICONE GEL SHEET BURN BLANKET HYDROGEL SHEET DRESSING, AMORPHOUS HYDROGEL WOUND DRESSING, HYDROGEL IMPREGNATED DRESSING, BURN DRESSING, BURN GEL, LUBRICANT PATIENT, STERILE LUBRICATING JELLY ELASTIC BANDAGE, STRETCH BANDAGE ALCOHOL PREP PAD DISPOSABLE UNDERPAD, PROTECTIVE UNDERWEAR, BRIEFS, PULL-UPS, DIAPERS HYDROCONDUCTIVE DRESSING, CALCIUM ALGINATE DRESSING, GELLING FIBER DRESSING, SUPER ABSORBENT DRESSING, BORDERED GAUZE DRESSING, WATERPROOF COMPOSITE DRESSING, ACTIVATED CHARCOAL DRESSING, CARBON FIBER DRESSING CLEANSING WIPES, WET WIPES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2025-12-28
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-12-28
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-12-28
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2025-12-28
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2025-12-28
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-12-28
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2025-12-28
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-12-28
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2025-12-28
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2025-12-28
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-12-28
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-12-28

Official Correspondent

Kaia Zhu

US Agent Details

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

Related Public Records

Same Entity

SYNTHETAH, LLC

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
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3041329419. Last updated year: 2026. Please use registration number 3041329419 when referencing this establishment in official correspondence.