SOHO MEDICAL CO., LTD.

FDA Device Registration & Listing · Nanjing Jiangsu, CN · Registration 3008676146

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
3008676146
FEI Number
3008676146
Entity Name
SOHO MEDICAL CO., LTD.
City/State/Country
Nanjing Jiangsu, CN
Establishment Address
91 BAIXIA ROAD, 10-11 FLOOR, SOHO HIGH HOPE BUILDING, Nanjing Jiangsu 210001, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
SOHO MEDICAL CO., LTD. (Owner Number: 10061219)
Owner / Operator Contact Address
91 BAIXIA ROAD, 10-11 FLOOR, SOHO HIGH HOPE BUILDING, Nanjing, CN-JS 210001, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Suction Catheter Nasopharyngeal Airway Aerosol mask Oxygen mask surgical instrument kit, disposable SURGICAL Dressing Kit Triangular bandage Abdominal pad ABD pads trauma pad gauze sponges swabs lap sponges gauze pad Gauze General Face Mask stretcher, hand-carried - Stretcher Stretcher non-adherent pad NAP pads Sterile pad non-woven sponges non-woven pad gauze pad Surgical Respirator Surgical Masks pack, hot or cold, disposable cotton applicator non-sterile Cotton swabs Ice Bag adhesive surgical tape adhesive tape medical tape plaster Tape adhesive plaster dressing Stylet,,Bougie, tracheal tube Crepe elastic bandage PBT bandage Rolled gauze Tweezers general plastic tweezers for first aid kit Eye pads

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2022-05-23
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2022-05-23
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2022-05-23
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2022-05-23
ILI Sling, Arm Physical Medicine Class 1 890.3640 2019-09-23
MHW Dressing, Compression General Hospital Class 1 880.5075 2019-09-23
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2019-09-23
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2020-03-27
FPP Stretcher, Hand-Carried General Hospital Class 1 880.6900 2022-05-23
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2019-09-23
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2019-09-23
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-27
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2022-05-23
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2019-09-23
KYR Bag, Ice General Hospital Class 1 880.6050 2022-05-23
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2019-09-23
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2022-05-23
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2019-09-23
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-09-23
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2019-09-23

Official Correspondent

Lan Ding

US Agent Details

Solomon Chen Email: regmed.connect@gmail.com Phone: (909) 4387898

Related Public Records

Same Entity

SOHO MEDICAL 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
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K102092 Prestige Ameritech PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES 2010-10-06
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2013 Invuity, Inc. 2
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008676146. Last updated year: 2026. Please use registration number 3008676146 when referencing this establishment in official correspondence.
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