Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044150131

FEI Number

3044150131

Entity Name

Shanghai Jolly Industrial Co., Ltd.

City/State/Country

Shanghai, CN

Establishment Address

Room 118, Building 20, No. 1-42, Lane 83, Hongxiang North Road, Lingang New Area, China (Shanghai) Pilot Free, Shanghai 200131, 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 Jolly Industrial Co., Ltd. (Owner Number: 10095428)

Owner / Operator Contact Address

Room 118, Building 20, No. 1-42, Lane 83, Hongxiang North Road, Lingang New Area, China (Shanghai) Pilot Free, Shanghai, CN-SH 200131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound dressing Silicone foam dressing I.V. film dressing Surgical film First aid plaster PU Film dressing Acne pacth Hydrocolloid adhesive bandage Ice pack X ray sensor holder Tongue depressor Body surface conduit fixing device Endotracheal holder Dental loope Caps Cap, surgical Gauze swab Gauze roll Cotton ball Gauze/sponge, nonresorbable for external use Floss, dental Face Shield Eye pad Collection Bottle Orthodontic kit Applicator resin, prebent tips Dental composite brush Dental bib Mixing bowl Dappen dish Wrapping sheet Isolation gown Shoe cover Prophy brush, prophy cup Prophy angle Cup, prophylaxis Dispenser, solid medication Pill container Cheek retractor Scissors Disposable mirror Disposable dental kits (probe, mirror, tweezer) Mirror, mouth Photo contrast board Cover, shoe, operating-room Aligner, bracket, orthodontic Stethoscope Toothbrush Polishing strips Coverall Beard cover Accessory, surgical apparel First aid kit Sampling swabs Swab Tougue depressor Applicator, absorbent tipped, non-sterile Cotton swab Alcohol swab Unit, syringe, air and/or water Air water syringe tip Ostomy Barrier Ring Ostomy Belt Ostomy Powder Ostomy Paste Skin protective film Surgical tape Disposable razors Instrument, surgical, disposable Hydrocolliod dressing Disposable dental cup Wax, dental, intraoral Apron, leaded Wrapping sheet Two piece Ostomy bag One piece Ostomy bag Disposable razors Digital thermometer Mixing spatula Urine bag Point, paper, endodontic Gutta-percha Ear cleaning syringe Dental dispenser syringe Mixing tips Dispenser gun Dental delivery tips Denture box Retainer box Disposable dental needles Dental Irrigation needle/tips Unit, operative dental, accessories Disposable plastic sleeves/covers Barrier film Disposable Dental evacuation traps Kinesiology tape Self adhesive bandage Cohesive bandage Rigid strapping tape Sports tape Underwrap foam tape Ostomy baseplate Nasal strips Fiber, medical, absorbent Cotton roll Waste bag Toenail treatment Heel patch Teeth model Dental simulator Silicone scar sheet Evacuator, oral cavity Matrix bands

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	2026-03-12
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-03-13
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2026-03-13
EHB	Collimator, X-Ray	Dental	Class 1	872.1840	2026-03-12
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2026-03-13
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2026-03-13
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2026-03-13
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2026-03-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-03-12
JES	Floss, Dental	Dental	Class 1	872.6390	2026-03-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2026-03-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2026-03-13
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-03-13
KXR	Applicator, Resin	Dental	Class 1	872.3140	2026-03-12
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2026-03-13
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2026-03-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2026-03-12
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2026-03-12
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2026-03-12
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2026-03-12
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2026-03-12
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2026-03-12
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2026-03-13
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2026-03-12
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2026-03-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2026-03-12
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2026-03-13
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2026-03-12
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2026-03-12
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2026-03-13
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2026-03-12
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-03-12
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2026-03-13
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2026-03-13
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2026-03-12
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2026-03-12
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2026-03-13
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2026-03-13
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-03-13
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-03-13
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2026-03-13
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2026-03-13
EKM	Gutta-Percha	Dental	Class 1	872.3850	2026-03-12
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2026-03-13
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2026-03-13
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2026-03-12
DZM	Needle, Dental	Dental	Class 1	872.4730	2026-03-12
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2026-03-12
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2026-03-12
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2026-03-13
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2026-03-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2026-03-12
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2026-03-13
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	Class 1	890.3475	2026-03-13
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2026-03-13
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2026-03-13
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2026-03-12
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2026-03-13

Official Correspondent

Quanjing Shu

US Agent Details

Fanfei Liu Email: U.S.agent@frosatechnology.com Phone: (346) 7358880

Related Public Records

Same Entity

Shanghai Jolly 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
K781675	General X-Ray, Inc.	X-RAY COLLIMATOR	1978-12-04
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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 3044150131. Last updated year: 2026. Please use registration number 3044150131 when referencing this establishment in official correspondence.