Data / Medical devices / China / Planet(shanghai) International Co.,ltd
Planet(shanghai) International Co.,ltd: FDA-registered device maker in shanghai, China, 6 510(k) clearances
Planet(shanghai) International Co.,ltd is registered with the FDA (registration 3008808082) in shanghai, China. It lists 93 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 19, 2020. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008808082
- Address
- RM., Tong Da Mansion No.1, Lane 600, Tianshan RD, shanghai, China, 200051
- Owner or operator
- Planet(Shanghai) international Co.,Ltd (10034846)
- Roles
- Exporter to the US
- First device listed
- January 7, 2011
- Registered through
- 2026
- Brand names listed
- ABSORBER, SALIVA, PAPER, ACCESSORY, SURGICAL APPAREL, ACME M559: Splint fngr/tong depres 6 X .69" NonSterlie, APPLICATOR, ABSORBENT TIPPED, NON-STERILE, APPLICATOR, ABSORBENT TIPPED, STERILE, Adhesive backed thermal skin patches, Anti Bacterial Bandage, BAG, ICE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Absorber, Saliva, Paper | KHR | 1 | Exporter to the US | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US | accessdata.fda.gov |
| Adhesive Backed Thermal Skin Patches | OMW | 1 | Exporter to the US | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Exporter to the US | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Exporter to the US | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Exporter to the US | accessdata.fda.gov |
| Band Or Belt, Pelvic Support | ISR | 1 | Exporter to the US | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Exporter to the US | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Exporter to the US | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Exporter to the US | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Exporter to the US | accessdata.fda.gov |
| Cage, Knee | ITM | 1 | Exporter to the US | accessdata.fda.gov |
| Cannula, Ear | JYC | 1 | Exporter to the US | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Exporter to the US | accessdata.fda.gov |
| Clip, Removable (Skin) | FZQ | 1 | Exporter to the US | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Exporter to the US | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Exporter to the US | accessdata.fda.gov |
| Degreaser, Skin, Surgical | KOY | 1 | Exporter to the US | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Exporter to the US | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Exporter to the US | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Exporter to the US | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Exporter to the US | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Exporter to the US | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Exporter to the US | accessdata.fda.gov |
| Epilator, High Frequency, Tweezer-Type | KCX | 1 | Exporter to the US | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US | accessdata.fda.gov |
| Finger Cot | LZB | 1 | Exporter to the US | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Exporter to the US | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Exporter to the US | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Exporter to the US | accessdata.fda.gov |
| Forceps | HTD | 1 | Exporter to the US | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Exporter to the US | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Exporter to the US | accessdata.fda.gov |
| Insoles, Medical | KYS | 1 | Exporter to the US | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Exporter to the US | accessdata.fda.gov |
| Joint, Hip, External Brace | ITS | 1 | Exporter to the US | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Exporter to the US | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Exporter to the US | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Abdominal | KTD | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Cervical-Thoracic, Rigid | IQF | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Corrective Shoe | KNP | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Rib Fracture, Soft | IPX | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Sacroiliac, Soft | IPW | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Truncal, For Dysmenorrhea | NJB | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Exporter to the US | accessdata.fda.gov |
| Pill Crusher/Cutter | OHY | 1 | Exporter to the US | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Exporter to the US | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Exporter to the US | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Exporter to the US | accessdata.fda.gov |
| Shoes, Operating-Room | FXW | 1 | Exporter to the US | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Exporter to the US | accessdata.fda.gov |
| Sling, Arm, Overhead Supported | ILE | 1 | Exporter to the US | accessdata.fda.gov |
| Snake Bite Suction Kit | KYP | 1 | Exporter to the US | accessdata.fda.gov |
| Splint, Clavicle | IQJ | 1 | Exporter to the US | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Exporter to the US | accessdata.fda.gov |
| Stocking, Elastic | ILG | 1 | Exporter to the US | accessdata.fda.gov |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | 2 | Exporter to the US | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Exporter to the US | accessdata.fda.gov |
| Support, Scrotal, Therapeutic | FQJ | 1 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| October 19, 2020 | K200821 | anti-bacterial bandage | FRO | Substantially Equivalent | Planet (Suzhou) Medical Products Co., Ltd. | accessdata.fda.gov |
| June 15, 2016 | K153496 | Disposable Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Rayxin Medical Products Co., Ltd. | accessdata.fda.gov |
| February 5, 2013 | K123050 | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) | LCX | Substantially Equivalent | Nantong Biotechnology Co., Ltd. | accessdata.fda.gov |
| August 24, 2011 | K110776 | DIGITAL THERMOMETER MT SERIES | FLL | Substantially Equivalent | Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
| October 8, 2010 | K102161 | BLUE SAIL INNOVATION | LYZ | Substantially Equivalent | Shandong Blue Sail Innovation Co., Ltd. | accessdata.fda.gov |
| February 6, 2006 | K051699 | SEJOY, MODEL MT-403 | FLL | Substantially Equivalent | Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 19, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.