Data / Medical devices / Hong Kong / Planet Holdings Limited
Planet Holdings Limited: FDA-registered device maker in Hong Kong, Hong Kong, 3 510(k) clearances
Planet Holdings Limited is registered with the FDA (registration 3016450032) in Hong Kong, Hong Kong. It lists 79 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 31, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016450032
- Address
- 2/F Hong Kong Trade CTR DES VOEUX RD CENTRAL, Hong Kong, Hong Kong, none
- Owner or operator
- Planet Holdings Limited (10062373)
- Roles
- Exporter to the US
- First device listed
- January 17, 2020
- Registered through
- 2027
- Brand names listed
- ABSORBER, SALIVA, PAPER, ACCESSORY, SURGICAL APPAREL, APPLICATOR, ABSORBENT TIPPED, NON-STERIL, APPLICATOR, ABSORBENT TIPPED, STERILE, Adhesive backed thermal skin patches, Anti-bacterial Bandage, BAG, ICE, BANDAGE, CAST 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Exporter to the US | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 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 |
| Pick, Massaging | JET | 1 | Exporter to the US | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | 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 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Exporter to the US | accessdata.fda.gov |
| Sling, Arm | ILI | 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 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 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 |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 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 |
|---|
| August 31, 2022 | K221507 | Disposable Blood Lancet | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| October 19, 2020 | K200821 | anti-bacterial bandage | FRO | Substantially Equivalent | Planet (Suzhou) Medical Products Co., Ltd. | accessdata.fda.gov |
| November 17, 2017 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) | CBP | Substantially Equivalent | Xiamen Compower Medical Tech. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 31, 2022. 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.