Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008808082

FEI Number

3008808082

Entity Name

PLANET(SHANGHAI) INTERNATIONAL CO.,LTD

City/State/Country

shanghai, CN

Establishment Address

RM. 805-807, TONG DA MANSION, NO.1, LANE 600, TIANSHAN RD, shanghai 200051, CN

Establishment Type(s)

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

Owner / Operator

Planet(Shanghai) international Co.,Ltd (Owner Number: 10034846)

Owner / Operator Contact Address

RM. 805-807, TONG DA MANSION, NO.1, LANE 600, TIANSHAN RD, shanghai, CN-SH 200051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COVER, SHOE, OPERATING-ROOM SHOE AND SHOE COVER, CONDUCTIVE Thermometer, electronic, clinical ABSORBER, SALIVA, PAPER MASK, SCAVENGING APPLICATOR, ABSORBENT TIPPED, NON-STERILE ORTHOSIS, SACROILIAC, SOFT SPLINT, CLAVICLE PACK, HOT OR COLD, DISPOSABLE ORTHOSIS, THORACIC Magnifying Tablet Cutter- Ready2Go Pill Pulverizer- Ready2Go Tablet Cutter -Ready2Go Deluxe Pill splitter - Ready2Go JOINT, HIP, EXTERNAL BRACE JOINT, KNEE, EXTERNAL BRACE ORTHOSIS, CERVICAL-THORACIC, RIGID ORTHOSIS, LIMB BRACE FLOSS, DENTAL Dispenser, solid medication ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB TOOTHBRUSH, MANUAL SUIT, SURGICAL FIBER, MEDICAL, ABSORBENT SLING, ARM, OVERHEAD SUPPORTED SUPPORT, SCROTAL, THERAPEUTIC PICK, MASSAGING Dressing,wound,occlusive Orthosis, truncal, for dysmenorrhea KN95 FACE MASK Ovulation Predictor Dressing,wound,hydrophilic ORTHOSIS, LUMBAR EPILATOR, HIGH FREQUENCY, TWEEZER-TYPE Vinyl patient examination glove SHOES, OPERATING-ROOM SUPPORT, ARM SLING, ARM CVS ABAC BDGS XL CVS HD AB BDG XL Anti Bacterial Bandage CVS FLX FAB XL CVS HD AB FAB BND CVS AB FT/KN BNDG CVS ANTBC FLX FAB CVS AB PADS XL CVS ANTBTC HD FAB CVS AB BDGS ASST CVS BNDG ASST VP CVS FLX FB AB BDG CVS FF AB BDG AST CVS ABAC FLX BDGS Dressing,wound,hydrogel w/out drug and/or biologic SPLINT, HAND, AND COMPONENTS BANDAGE, CAST GOWN, EXAMINATION ACCESSORY, SURGICAL APPAREL DRESSING, COMPRESSION FORCEPS Repaid INSOLES, MEDICAL PAD, EYE First aid kit without drug Adhesive backed thermal skin patches ORTHOSIS, LUMBO-SACRAL Finger Cot FORCEPS, GENERAL & PLASTIC SURGERY DEPRESSOR, TONGUE, NON-SURGICAL ACME M559: Splint fngr/tong depres 6 X .69" NonSterlie JOINT, ANKLE, EXTERNAL BRACE EVERGRAND SURGICAL CAPS; FACE MASK; MASKS GOWNS PACK, HOT OR COLD, REUSEABLE Rapaid GARMENT, PROTECTIVE, FOR INCONTINENCE scar sheets scar tape DILATOR, NASAL DRIVER, SURGICAL, PIN STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL APPLICATOR, ABSORBENT TIPPED, STERILE EGENS One Step HOG Urine Pregnancy Test Kit (Cassette) ORTHOSIS, CERVICAL Wound Closure device ORTHOSIS, RIB FRACTURE, SOFT SCISSORS, GENERAL, SURGICAL Reminder, medication Repaid Bandage, liquid, skin protectant CPR Mask W/One WayValve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2011-01-07
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2011-01-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-04-16
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2011-01-07
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2011-01-07
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-01-07
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2011-10-08
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2011-10-08
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2011-01-07
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2011-10-08
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2016-05-24
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2011-10-07
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2011-10-07
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2011-10-08
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2011-10-07
JES	Floss, Dental	Dental	Class 1	872.6390	2011-01-07
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2011-01-07
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2011-10-08
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2011-01-07
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2011-01-07
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2011-01-07
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2011-01-07
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2012-11-23
JET	Pick, Massaging	Dental	Class 1	872.6650	2011-01-07
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2011-01-07
NJB	Orthosis, Truncal, For Dysmenorrhea	Physical Medicine	Class 1	890.3490	2011-10-08
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-27
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2015-06-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2011-01-07
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2011-10-08
KCX	Epilator, High Frequency, Tweezer-Type	General, Plastic Surgery	Class 1	878.5360	2011-01-07
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2011-01-10
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2011-01-10
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2018-06-13
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2011-10-07
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2011-01-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-12-04
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2011-01-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2011-01-07
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2011-01-07
FME	Gown, Examination	General Hospital	Class 1	880.6265	2011-01-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-07-18
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2011-01-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2011-01-07
NUQ	Pad, Menstrual, Reusable	Obstetrics/Gynecology	Class 1	884.5435	2015-06-04
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2011-01-07
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2011-01-07
KYP	Snake Bite Suction Kit	General Hospital	Class 1	880.5740	2016-06-07
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2011-01-26
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2011-01-28
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2011-10-08
LZB	Finger Cot	General Hospital	Class 1	880.6250	2020-08-16
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-01-07
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2011-01-10
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2011-10-07
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2017-04-06
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2011-01-07
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2011-12-25
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-07-02
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2011-10-25
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2011-01-07
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2011-01-07
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2011-01-07
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2016-11-23
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-11-23
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2011-10-08
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2024-07-02
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2011-10-08
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-01-07
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2011-01-28
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-06-13
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2015-06-04
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2011-01-07
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2018-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

Yulu Wang Email: yuluw@m-cure.net Phone: (626) 8399001

Related Public Records

Same Entity

Planet(Shanghai) 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008808082. Last updated year: 2026. Please use registration number 3008808082 when referencing this establishment in official correspondence.