Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017417635

FEI Number

3017417635

Entity Name

PLANET (ANHUI) INTERNATIONAL CO, LTD

City/State/Country

Chuzhou Anhui, CN

Establishment Address

No.2066 Jianshe West Road ,High-tech Zone, Chuzhou Anhui 239300, CN

Establishment Type(s)

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

Owner / Operator

PLANET (ANHUI) INTERNATIONAL CO, LTD (Owner Number: 10076399)

Owner / Operator Contact Address

No.2066 Jianshe West Road ,High-tech Zone, Chuzhou, CN-AH CN-34, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SHOE AND SHOE COVER, CONDUCTIVE ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB COVER, SHOE, OPERATING-ROOM GARMENT, PROTECTIVE, FOR INCONTINENCE INSOLES, MEDICAL SCISSORS, GENERAL, SURGICAL SHOES, OPERATING-ROOM BAG, ICE CANNULA, EAR APPLICATOR, ABSORBENT TIPPED, NON-STERILE MOUTHPIECE, BREATHING ORTHOSIS, CORRECTIVE SHOE JOINT, HIP, EXTERNAL BRACE Disinfectant, medical devices PACK, HOT OR COLD, DISPOSABLE SPLINT, CLAVICLE MASK, OXYGEN, NON-REBREATHING Dressing, wound, occlusive ORTHOSIS, RIB FRACTURE, SOFT BANDAGE, CAST ORTHOSIS, THORACIC PICK, MASSAGING Dressing, wound, hydrogel without drug and/or biologic SUPPORT, ARM ORTHOSIS, LIMB BRACE DEPRESSOR, TONGUE, NON-SURGICAL STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES) STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL ORTHOSIS, CERVICAL DRIVER, SURGICAL, PIN EPILATOR, HIGH FREQUENCY, TWEEZER-TYPE DEGREASER, SKIN, SURGICAL SPLINT, HAND, AND COMPONENTS SLING, ARM, OVERHEAD SUPPORTED CAGE, KNEE Gauze / sponge,nonresorbable for external use STOCKING, ELASTIC ACCESSORY, SURGICAL APPAREL ORTHOSIS, ABDOMINAL Pack, hot or cold, reusable Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance Snake Bite Suction Kit FORCEPS Respirator, surgical ABSORBER, SALIVA, PAPER ORTHOSIS, LUMBO-SACRAL COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT DRESSING, COMPRESSION JOINT, ANKLE, EXTERNAL BRACE NAC - Dressing, wound, hydrophilic Acne healing patches FLOSS, DENTAL CONTAINER, LIQUID MEDICATION, GRADUATED BEDDING, DISPOSABLE, MEDICAL SLING, ARM Gown, examination Non-Woven Adhesive lsland Dressings ORTHOSIS, SACROILIAC, SOFT BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION APPLICATOR, ABSORBENT TIPPED, STERILE BOTTLE, HOT/COLD WATER SUIT, SURGICAL ORTHOSIS, LUMBAR Bandage, liquid, skin protectant Reminder, medication FORCEPS, GENERAL & PLASTIC SURGERY Finger cot PAD, EYE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-09-02
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2020-09-02
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-09-02
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2020-09-02
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2020-09-02
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-09-02
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-09-02
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2020-09-02
JYC	Cannula, Ear	General, Plastic Surgery	Class 1	878.4800	2020-09-02
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-09-02
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2020-09-02
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2020-09-02
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2020-09-02
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-09-02
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2020-09-02
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2020-09-02
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2020-09-02
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-09-02
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2020-09-02
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-09-02
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2020-09-02
JET	Pick, Massaging	Dental	Class 1	872.6650	2020-09-02
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2020-09-02
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2020-09-02
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2020-09-02
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2020-09-02
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2020-09-02
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2020-09-01
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2020-09-02
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2020-09-02
KCX	Epilator, High Frequency, Tweezer-Type	General, Plastic Surgery	Class 1	878.5360	2020-09-02
KOY	Degreaser, Skin, Surgical	General, Plastic Surgery	Class 1	878.4730	2020-09-02
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2020-09-02
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2020-09-02
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2020-09-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-09-01
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2020-09-02
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-09-02
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2020-09-02
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2020-09-02
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-09-03
KYP	Snake Bite Suction Kit	General Hospital	Class 1	880.5740	2020-09-03
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2020-09-02
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-09-02
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2020-09-02
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2020-09-02
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2020-09-02
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-09-02
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2020-09-02
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-09-01
JES	Floss, Dental	Dental	Class 1	872.6390	2020-09-02
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2020-09-02
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-09-02
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2020-09-02
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2020-07-17
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-09-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-07-17
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2020-09-02
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2020-09-01
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-09-02
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2020-09-02
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-09-02
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2020-09-02
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2020-09-02
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2020-09-02
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-09-02
LZB	Finger Cot	General Hospital	Class 1	880.6250	2020-09-02
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2020-09-01

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PLANET (ANHUI) INTERNATIONAL 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
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.

Similar Registrations

Registration Number	Establishment Name	Location
3008808082	PLANET(SHANGHAI) INTERNATIONAL CO.,LTD	shanghai, CN
3045058049	BOEN HEALTHCARE CO., LTD.	Suzhou Jiangsu, CN
3003965134	RECE INTERNATIONAL CORP.	Miami Lakes, FL, US
3009716062	MINRA GARMENTS (PVT) LTD	Puttlam North Western, LK
3005271071	BIOMED PLASTICS CO.	TAICANG, JIANGSU, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017417635. Last updated year: 2026. Please use registration number 3017417635 when referencing this establishment in official correspondence.