Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010374920

FEI Number

3010374920

Entity Name

NINGBO JENIUS POLYMER SCI-TECH CO., LTD

City/State/Country

YinZhou District, Ningbo Zhejiang, CN

Establishment Address

No 2112 Ningheng South Road, Hengxi Town, YinZhou District, Ningbo Zhejiang 315192, CN

Establishment Type(s)

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

Owner / Operator

Ningbo Jenius Medical Tech Co., Ltd. (Owner Number: 10044264)

Owner / Operator Contact Address

No. 2112, Ningheng South Road, Hengxi Town Yinzhou District, Ningbo, CN-ZJ 315100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tongue Depressor Suit, Surgical SCISSORS, GENERAL, SURGICAL FORCEPS PAD, EYE Dressing, wound, hydrophilic Bandage, liquid, skin protectant Sling Gauze Bedding Tape Examination Light First Aid Kit Hot/Cold Water Bottle Occlusive Wound Dressing Applicator Drape Endoscopic bite block Oxygen Mask Surgical Apparel Shoe Cover Tourniquet INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2016-09-13
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-25
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-09-13
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-09-13
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2016-09-13
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-09-13
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2016-09-13
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2016-09-13
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-09-13
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-09-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-09-13
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2016-09-13
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2015-09-06
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2016-09-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-09-13
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2016-09-13
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2019-01-28
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2019-01-21
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-09-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2016-09-13
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-03-25
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2013-05-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-09-13

Official Correspondent

No official correspondent registered.

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Ningbo Jenius Medical Tech 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

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 3010374920. Last updated year: 2026. Please use registration number 3010374920 when referencing this establishment in official correspondence.