Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006542380

FEI Number

3006542380

Entity Name

JOYKEY INDUSTRIAL (PINGHU) LIMITED

City/State/Country

Pinghu City Zhejiang, CN

Establishment Address

2nd Floor East, Building 2, No.2000, Xingping Il RD, Pinghu Economic Development Zone, Pinghu City Zhejiang 314200, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Joykey Industrial (Pinghu) Limited (Owner Number: 10079926)

Owner / Operator Contact Address

2nd Floor East, Building 2, No.2000, Xingping Il RD, Pinghu Economic Development Zone, Pinghu City, CN-ZJ 314200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TRAP, STERILE SPECIMEN Container, Specimen, Sterile Dressing, wound, occlusive Catheter And Tip, Suction CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE Dressing, Wound, Hydrophilic ACCESSORIES, CATHETER COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER Foley Catheter Kit (Excludes Hiv Testing) Container, Specimen, Non-Sterile CATHETERS, SUCTION, TRACHEOBRONCHIAL DEVICE, INTRAVASCULAR CATHETER SECUREMENT Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE BANDAGE, CAST Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Syringe, Irrigating (Non Dental) Kit, surgical instrument, disposable CATHETER, IRRIGATION Stylet, Tracheal Tube Tape and bandage, adhesive AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE Drape, surgical, exempt ACCESSORY, SURGICAL APPAREL Surgery tray Set, Administration, Intravascular Light, surgical, accessories APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED Set, Administration, Intravascular FIBER, MEDICAL, ABSORBENT Catheter care tray AIRWAY, NASOPHARYNGEAL CONNECTOR, CATHETER REMOVER, INTRAUTERINE DEVICE, CONTRACEPTIVE, HOOK-TYPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2025-01-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2021-04-29
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-01-20
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2021-04-29
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2025-01-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-01-20
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-01-20
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2022-03-08
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2021-06-06
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-06-06
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2025-01-20
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2025-01-20
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2025-01-20
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-01-20
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2025-01-20
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2021-04-29
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2021-04-29
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-01-20
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2025-01-20
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2025-01-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-01-20
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2025-01-20
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-01-20
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-01-04
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-01-20
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2024-11-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-06-06
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2025-01-20
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2025-01-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-06-06
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-01-20
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2024-11-25
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2025-01-20
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-01-20
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2025-01-20

Official Correspondent

Phil Chuang

US Agent Details

James St WU Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Joykey Industrial (Pinghu) Limited

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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21

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.

Similar Registrations

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1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3005327291	SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.	SHANGHAI, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006542380. Last updated year: 2026. Please use registration number 3006542380 when referencing this establishment in official correspondence.