FDA Registration
Active
🇭🇰 Hong Kong
PLANET HOLDINGS LIMITED
Reg #: 3016450032
·
FEI: 3016450032
·
Expires 2026
Products
79
Proprietary Names
74
Establishment Types
1
Classifications
79
Registration Details
- Registration Name
- PLANET HOLDINGS LIMITED
- Registration Number
- 3016450032
- FEI Number
- 3016450032
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2/F Hong Kong Trade CTR, 161-167 DES VOEUX RD CENTRAL
- City
- Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K200821
Owner / Operator
- Firm Name
- Planet Holdings Limited
- Operator Number
- 10062373
- Address
- 2/F Hong Kong Trade CTR, 161-167 DES VOEUX RD CENTRAL
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- none
- Country
- HK
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pick, Massaging | JET | Class 1 | Dental | No | 2020-07-13 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2020-07-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2020-07-13 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2020-07-13 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2020-07-13 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2020-07-13 |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2020-07-02 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2020-07-13 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-07-13 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2020-07-13 |
| Reminder, Medication | NXQ | Class 1 | Physical Medicine | No | 2020-07-13 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-07-13 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2020-07-13 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2020-07-13 |
| Orthosis, Truncal, For Dysmenorrhea | NJB | Class 1 | Physical Medicine | No | 2020-07-13 |
| Cannula, Ear | JYC | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2020-07-13 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-08-12 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2020-07-13 |
| Shoes, Operating-Room | FXW | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2020-07-13 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2020-07-13 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2020-07-13 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2020-07-13 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2020-07-13 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2020-07-13 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2020-07-13 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-07-13 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-07-13 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2024-01-23 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2020-07-13 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2020-07-13 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2020-07-13 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2020-07-13 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2020-07-13 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2020-07-13 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2020-07-13 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2020-07-13 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2020-07-13 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-01-17 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2020-07-13 |
| Floss, Dental | JES | Class 1 | Dental | No | 2020-07-13 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-07-13 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-08-13 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2020-07-13 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2020-07-13 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2024-03-28 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2020-07-13 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2020-07-13 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2020-07-13 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2024-07-15 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2020-01-22 |
| Degreaser, Skin, Surgical | KOY | Class 1 | General, Plastic Surgery | No | 2020-07-01 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2020-07-13 |
| Epilator, High Frequency, Tweezer-Type | KCX | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2020-07-13 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2020-07-13 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2020-07-13 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2024-03-04 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2020-07-13 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2020-01-17 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2024-07-18 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2020-07-13 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2020-07-13 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2020-07-13 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2020-08-20 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2020-07-13 |
Proprietary Names
PICK, MASSAGING
DILATOR, NASAL
DISPENSER, LIQUID MEDICATION
CAGE, KNEE
ORTHOSIS, LUMBAR
Pack, hot or cold, reusable
STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL
FORCEPS
BANDAGE, ELASTIC
Disinfectant, medical devices
FORCEPS, GENERAL & PLASTIC SURGERY
SHOE AND SHOE COVER, CONDUCTIVE
PAD, EYE
SUPPORT, ARM
Reminder, medication
MASK, SCAVENGING
BANDAGE, CAST
FIBER, MEDICAL, ABSORBENT
Orthosis, truncal, for dysmenorrhea
CANNULA, EAR
GARMENT, PROTECTIVE, FOR INCONTINENCE
Anti-bacterial Bandage
INSOLES, MEDICAL
SHOES, OPERATING-ROOM
BOTTLE, HOT/COLD WATER
Dressing, wound, occlusive
STOCKING, ELASTIC
SCISSORS, GENERAL, SURGICAL
ORTHOSIS, ABDOMINAL
STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
DEPRESSOR, TONGUE, NON-SURGICAL
TOOTHBRUSH, MANUAL
SPLINT, HAND, AND COMPONENTS
Gown, examination
APPLICATOR, ABSORBENT TIPPED, STERILE
Adhesive backed thermal skin patches
ORTHOSIS, LUMBO-SACRAL
Dressing, wound, hydrogel without drug and/or biologic
CONTAINER, LIQUID MEDICATION, GRADUATED
ORTHOSIS, THORACIC
DRESSING, COMPRESSION
PACK, HOT OR COLD, DISPOSABLE
SPLINT, CLAVICLE
Gauze / sponge,nonresorbable for external use
ORTHOSIS, CERVICAL
JOINT, HIP, EXTERNAL BRACE
First Aid Only
CVS Health
DRIVER, SURGICAL, PIN
ORTHOSIS, RIB FRACTURE, SOFT
FLOSS, DENTAL
BEDDING, DISPOSABLE, MEDICAL
COVER, SHOE, OPERATING-ROOM
ABSORBER, SALIVA, PAPER
JOINT, ANKLE, EXTERNAL BRACE
ORTHOSIS, CERVICAL-THORACIC, RIGID
Bandage, liquid, skin protectant
SUIT, SURGICAL
SLING, ARM
Wound closure
DEGREASER, SKIN, SURGICAL
ACCESSORY, SURGICAL APPAREL
ORTHOSIS, SACROILIAC, SOFT
EPILATOR, HIGH FREQUENCY, TWEEZER-TYPE
BAG, ICE
MASK, OXYGEN, NON-REBREATHING
ORTHOSIS, LIMB BRACE
Dispenser, solid medication
Scar Sheets tape
ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB
ORTHOSIS, CORRECTIVE SHOE
APPLICATOR, ABSORBENT TIPPED, NON-STERIL
Finger cot
JOINT, KNEE, EXTERNAL BRACE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device