Planet(Shanghai) International Co., Ltd.
Registered establishment in Shanghai, China. 93 device types.
Planet(Shanghai) International Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Forceps, Bag, Ice and 91 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | PLANET(SHANGHAI) INTERNATIONAL CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008808082 |
| FEI number | 3008808082 |
| Establishment type | Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | RM. 805-807, TONG DA MANSION |
| Postal code | 200051 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Absorber, Saliva, Paper | 2011 | 86 |
| Accessory, Surgical Apparel | Class 1 | Accessory, Surgical Apparel | 2018 | 439 |
| Adhesive Backed Thermal Skin Patches | Class 1 | Adhesive backed thermal skin patches | 2011 | 48 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Applicator, Absorbent Tipped, NON-Sterile | 2011 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Applicator, Absorbent Tipped, Sterile | 2011 | 100 |
| Bag, Ice | Class 1 | BAG, ICE | 2011 | 86 |
| Band Or Belt, Pelvic Support | Class 1 | Repaid | 2015 | 54 |
| Bandage, Cast | Class 1 | Bandage, Cast | 2011 | 81 |
| Bandage, Elastic | Class 1 | Bandage, Elastic | 2011 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | Bandage, liquid, skin protectant | 2011 | 41 |
| Bedding, Disposable, Medical | Class 1 | Bedding, Disposable, Medical | 2011 | 308 |
| Bottle, Hot/Cold Water | Class 1 | Bottle, HOT/Cold Water | 2011 | 37 |
| Cage, Knee | Class 1 | Cage, Knee | 2011 | 15 |
| Cannula, Ear | Class 1 | Cannula, EAR | 2011 | 3 |
| Cleanser, Denture, Over The Counter | Class 1 | Cleanser, Denture, Over THE Counter | 2017 | 34 |
| Clip, Removable (Skin) | Class 1 | Wound Closure device | 2024 | 15 |
| Container, Liquid Medication, Graduated | Class 1 | Container, Liquid Medication, Graduated | 2011 | 68 |
| Continuous Measurement Thermometer | Class 2 | Thermometer, electronic, clinical | 2011 | 115 |
| Cover, Shoe, Operating-Room | Class 1 | Cover, Shoe, Operating-Room | 2011 | 176 |
| Degreaser, Skin, Surgical | Class 1 | Degreaser, Skin, Surgical | 2011 | 7 |
| Depressor, Tongue, Non-Surgical | Class 1 | Depressor, Tongue, NON-Surgical, ACME M559: Splint fngr/tong depres 6 X.69″ NonSterlie | 2011 | 100 |
| Dilator, Nasal | Class 1 | Dilator, Nasal | 2011 | 55 |
| Disinfectant, Medical Devices | Class 1 | Disinfectant, medical devices | 2011 | 197 |
| Dispenser, Liquid Medication | Class 1 | Dispenser, Liquid Medication | 2011 | 86 |
| Dispenser, Solid Medication | Class 1 | Dispenser, solid medication | 2011 | 68 |
| Dress, Surgical | Class 1 | Evergrand Surgical Caps; Face Mask; Masks Gowns | 2017 | 71 |
| Dressing, Compression | Class 1 | Dressing, Compression | 2011 | 87 |
| Dressing, Wound, Drug | Class U | CVS HD AB FAB BND, CVS AB Bdgs Asst, CVS Abac Bdgs XL, Anti Bacterial Bandage, CVS FF AB BDG AST, CVS Abac FLX Bdgs and 8 more | 2020 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Dressing,wound,hydrogel w/out drug and/or biologic | 2011 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Dressing,wound,hydrophilic | 2011 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Dressing,wound,occlusive | 2011 | 183 |
| Driver, Surgical, Pin | Class 1 | Driver, Surgical, PIN | 2011 | 12 |
| Elastomer, Silicone, For Scar Management | Class 1 | scar sheets, scar tape | 2024 | 85 |
| Epilator, High Frequency, Tweezer-Type | Class 1 | Epilator, High Frequency, Tweezer-Type | 2011 | 13 |
| Fiber, Medical, Absorbent | Class 1 | Fiber, Medical, Absorbent | 2011 | 172 |
| Finger Cot | Class 1 | Finger Cot | 2020 | 29 |
| First Aid Kit With Drug | Class N | First Aid Kit with drug | 2011 | 57 |
| First Aid Kit Without Drug | Class 1 | First aid kit without drug | 2011 | 132 |
| Floss, Dental | Class 1 | Floss, Dental | 2011 | 151 |
| Forceps | Class 1 | Forceps | 2011 | 99 |
| Forceps, General & Plastic Surgery | Class 1 | Forceps, General & Plastic Surgery | 2011 | 27 |
| Garment, Protective, For Incontinence | Class 1 | Garment, Protective, FOR Incontinence, Rapaid | 2011 | 181 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze/sponge,nonresorbable for external use | 2011 | 266 |
| Gown, Examination | Class 1 | Gown, Examination | 2011 | 109 |
| Insoles, Medical | Class 1 | Insoles, Medical | 2011 | 34 |
| Joint, Ankle, External Brace | Class 1 | Joint, Ankle, External Brace | 2011 | 134 |
| Joint, Hip, External Brace | Class 1 | Joint, HIP, External Brace | 2011 | 33 |
| Joint, Knee, External Brace | Class 1 | Joint, Knee, External Brace | 2011 | 137 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | EGENS One Step HOG Urine Pregnancy Test Kit (Cassette) | 2016 | 30 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Mask, Oxygen, NON-Rebreathing | 2011 | 72 |
| Mask, Scavenging | Class 1 | Mask, Scavenging | 2011 | 158 |
| Mask, Surgical | Class 2 | 2018 | 125 | |
| Mouthpiece, Breathing | Class 1 | CPR Mask W/One WayValve | 2018 | 67 |
| Non-Surgical Gown | Class 1 | 2018 | 318 | |
| Orthosis, Abdominal | Class 1 | Orthosis, Abdominal | 2011 | 21 |
| Orthosis, Cervical | Class 1 | Orthosis, Cervical | 2011 | 114 |
| Orthosis, Cervical-Thoracic, Rigid | Class 1 | Orthosis, Cervical-Thoracic, Rigid | 2011 | 30 |
| Orthosis, Corrective Shoe | Class 1 | Orthosis, Corrective Shoe | 2011 | 51 |
| Orthosis, Limb Brace | Class 1 | Orthosis, Limb Brace | 2011 | 144 |
| Orthosis, Lumbar | Class 1 | Orthosis, Lumbar | 2011 | 110 |
| Orthosis, Lumbo-Sacral | Class 1 | Orthosis, Lumbo-Sacral | 2011 | 39 |
| Orthosis, Rib Fracture, Soft | Class 1 | Orthosis, RIB Fracture, Soft | 2011 | 12 |
| Orthosis, Sacroiliac, Soft | Class 1 | Orthosis, Sacroiliac, Soft | 2011 | 8 |
| Orthosis, Thoracic | Class 1 | Orthosis, Thoracic | 2011 | 30 |
| Orthosis, Truncal, For Dysmenorrhea | Class 1 | Orthosis, truncal, for dysmenorrhea | 2011 | 8 |
| Orthosis, Truncal/Orthosis, Limb | Class 1 | Orthosis, Truncal/Orthosis, Limb | 2011 | 68 |
| Pack, Hot Or Cold, Disposable | Class 1 | Pack, HOT OR Cold, Disposable | 2011 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | Pack, HOT OR Cold, Reuseable | 2011 | 178 |
| Pad, Eye | Class 1 | PAD, EYE | 2011 | 100 |
| Pad, Menstrual, Reusable | Class 1 | Repaid | 2015 | 31 |
| Pad, Menstrual, Unscented | Class 1 | PAD, Menstrual, Unscented | 2017 | 132 |
| Pick, Massaging | Class 1 | Pick, Massaging | 2011 | 46 |
| Pill Crusher/Cutter | Class 1 | Magnifying Tablet Cutter- Ready2Go, Pill Pulverizer- Ready2Go, Tablet Cutter -Ready2Go, Deluxe Pill splitter – Ready2Go | 2016 | 41 |
| Reminder, Medication | Class 1 | Reminder, medication | 2011 | 15 |
| Respirator, Surgical | Class 2 | KN95 Face Mask | 2020 | 118 |
| Scissors, General, Surgical | Class 1 | Scissors, General, Surgical | 2011 | 83 |
| Shoe And Shoe Cover, Conductive | Class 1 | Shoe AND Shoe Cover, Conductive | 2011 | 32 |
| Shoes, Operating-Room | Class 1 | Shoes, Operating-Room | 2011 | 6 |
| Sling, Arm | Class 1 | Sling, ARM | 2011 | 126 |
| Sling, Arm, Overhead Supported | Class 1 | Sling, ARM, Overhead Supported | 2011 | 31 |
| Snake Bite Suction Kit | Class 1 | 2016 | 4 | |
| Splint, Clavicle | Class 1 | Splint, Clavicle | 2011 | 31 |
| Splint, Hand, And Components | Class 1 | Splint, Hand, AND Components | 2011 | 144 |
| Stocking, Elastic | Class 1 | Stocking, Elastic | 2011 | 32 |
| Strip, Temperature, Forehead, Liquid Crystal | Class 2 | Strip, Temperature, Forehead, Liquid Crystal | 2011 | 17 |
| Suit, Surgical | Class 1 | Suit, Surgical | 2011 | 74 |
| Support, Arm | Class 1 | Support, ARM | 2011 | 72 |
| Support, Scrotal, Therapeutic | Class 1 | Support, Scrotal, Therapeutic | 2012 | 9 |
| Tape And Bandage, Adhesive | Class 1 | Tape and bandage, adhesive, CVS WP Fngr Bndg, CVS Bndg Gntl ADH, CVS HD WP BDG 1SZ, CVS Bndg WP TAN | 2011 | 353 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Ovulation Predictor | 2015 | 38 |
| Toothbrush, Manual | Class 1 | Toothbrush, Manual | 2011 | 244 |
| Vinyl Patient Examination Glove | Class 1 | Vinyl patient examination glove | 2011 | 72 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | EGENS One Step HOG Urine Pregnancy Test Kit (Cassette) | 2016 | 16 |
Clearances
No clearance names Planet(Shanghai) International Co., Ltd. as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200821 | 2020-10-19 | FRO | Traditional | Planet (Suzhou) Medical Products Co., Ltd. |
| K153496 | 2016-06-15 | FXX | Traditional | Xiantao Rayxin Medical Products Co., Ltd. |
| K123050 | 2013-02-05 | LCX | Traditional | Nantong Biotechnology Co., Ltd. |
| K110776 | 2011-08-24 | FLL | Special | Sejoy Electronics & Instruments Co., Ltd. |
| K102161 | 2010-10-08 | LYZ | Traditional | Shandong Blue Sail Innovation Co Ltd |
| K051699 | 2006-02-06 | FLL | Traditional | Sejoy Electronics & Instruments Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | First aid band aids, Wound plasters, Fever cooling patches, First aid kits |
|---|---|
| Certifications | FDA 510K, NDC registration |
| Export markets | Over 100 countries including North America, Europe, Australia, South America, Africa, Asia |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.