Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031582434

FEI Number

3031582434

Entity Name

SHANGHAI LIONS INDUSTRIAL CO.,LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

Building B Room 1215, No. 168 Cheng South Rdd,Pudong, SHANGHAI 201399, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHANGHAI LIONS INDUSTRIAL CO.,LTD. (Owner Number: 10090728)

Owner / Operator Contact Address

ROOM 1215,BUILDING B,NO.168 CHENGNAN ROAD,PUDONG, SHANGHAI, CN-NOTA 201399, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silicone Foam Dressing First aid plaster Wound dressing surgical film wax, dental, intraoral aligner, bracket, orthodontic tourniquet Hydrocolliod dressing Face Shield Eye pad gutta-percha wrapping sheet tray, surgical Mixing spatula Disposable dental cup ear cleaning syringe unit, operative dental, accessories disposable Dental evacuation traps Disposable plastic sleeves/covers Barrier film cover, shoe, operating-room Bandage (cohesive bandage, elastic bandage) Sports tape (foam tape, muscle tape, surgical tape) Shoe cover Wrapping sheet Isolation gown mouthpiece, saliva ejector cup, prophylaxis Prophy brush, prophy cup Prophy angle retainer box Denture box Teeth model Dental simulator rigid strapping tape self adhesive bandage underwrap foam tape kinesiology tape cohesive bandage sports tape Toenail Treatment heel patch Mixing tips Dental dispenser syringe Dental delivery tips Dispenser gun Dental diamond bur Toothbrush Disposable razors One piece Ostomy bag Two piece Ostomy bag Collection Bottle Ostomy Paste Ostomy Barrier Ring Ostomy Belt Skin protective film Ostomy Powder point, paper, endodontic Urine bag Disposable Dental Needles dental Irrigation needle/tips Gauze swab Gauze/sponge, nonresorbable for external use Gauze roll cotton ball dung cup urine cup Nasal Strips BITE WING TABS ice pack Acne pacth Hydrocolloid adhesive bandage Orthodontic kit silicone scar sheet paper test Endo bur holder/cleanser cap, surgical Caps Mixing pad Polishing strips APPLICATOR, ABSORBENT TIPPED, NON-STERILE; Swab; Alcohol swab; Cotton swab; Tougue depressor; sampling swabs Ostomy baseplate X ray sensor holder Air prophy unit Diamond grinting head instruments, dental hand, disposable Irrigation needles, Plastic wedge, wooden wedge Apron, leaded stethoscope dental Composite brush Applicator Resin, prebent tips waste bag tray, impression, preformed digital thermometer Dappen dish Mixing bowl pill container Dispenser, solid medication X-ray Barrier envelope fiber, medical, absorbent, Cotton roll Matrix bands floss, dental

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-05-07
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-05-07
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2024-05-07
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2025-09-11
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2026-02-26
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-05-07
EKM	Gutta-Percha	Dental	Class 1	872.3850	2024-05-07
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-09-11
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-05-07
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2025-09-11
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2025-09-11
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2025-09-11
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2024-05-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2024-05-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-05-07
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-05-07
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-05-07
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2024-05-07
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2024-05-07
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2025-09-11
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2025-08-20
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	Class 1	890.3475	2025-09-11
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2025-09-11
EJL	Bur, Dental	Dental	Class 1	872.3240	2025-09-11
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-05-07
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-09-11
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2026-02-26
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2026-02-26
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2026-02-26
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2024-05-07
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-09-11
DZM	Needle, Dental	Dental	Class 1	872.4730	2024-05-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-05-07
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2025-09-11
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2025-08-22
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2026-01-21
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2025-09-11
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-02-26
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2025-09-11
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2025-09-11
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2025-09-11
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2025-09-11
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-05-07
PWL	Oral Surgery Tray	Dental	Class 1	872.4565	2025-09-11
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2025-09-11
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-05-07
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2026-02-26
EHB	Collimator, X-Ray	Dental	Class 1	872.1840	2025-08-04
NYG	Lapping Tool Kit	Dental	Class 1	872.4565	2025-09-11
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-05-07
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2024-05-07
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2025-09-11
KXR	Applicator, Resin	Dental	Class 1	872.3140	2024-05-07
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2025-09-11
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2024-05-07
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-09-11
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2025-09-11
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2024-05-07
IXA	Cassette, Radiographic Film	Radiology	Class 2	892.1850	2025-09-11
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2024-05-07
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2025-09-11
JES	Floss, Dental	Dental	Class 1	872.6390	2024-05-07

Official Correspondent

WENXIU GUAN

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

SHANGHAI LIONS INDUSTRIAL 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

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 3031582434. Last updated year: 2026. Please use registration number 3031582434 when referencing this establishment in official correspondence.