Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016450032

FEI Number

3016450032

Entity Name

PLANET HOLDINGS LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

2/F Hong Kong Trade CTR, 161-167 DES VOEUX RD CENTRAL, Hong Kong none, HK

Establishment Type(s)

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

Owner / Operator

Planet Holdings Limited (Owner Number: 10062373)

Owner / Operator Contact Address

2/F Hong Kong Trade CTR, 161-167 DES VOEUX RD CENTRAL, Hong Kong, HK-NOTA none, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JET	Pick, Massaging	Dental	Class 1	872.6650	2020-07-13
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2020-07-13
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2020-07-13
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2020-07-13
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2020-07-13
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2020-07-13
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2020-07-02
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2020-07-13
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-07-13
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-07-13
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-07-13
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-07-13
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2020-07-13
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2020-07-13
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2020-07-13
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-07-13
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-07-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2020-07-13
NJB	Orthosis, Truncal, For Dysmenorrhea	Physical Medicine	Class 1	890.3490	2020-07-13
JYC	Cannula, Ear	General, Plastic Surgery	Class 1	878.4800	2020-07-13
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2020-07-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-08-12
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2020-07-13
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-13
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2020-07-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-07-13
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2020-07-13
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-07-13
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2020-07-13
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2020-07-13
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2020-07-13
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2020-07-13
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2020-07-13
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-07-13
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-07-13
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2024-01-23
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2020-07-13
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2020-07-13
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2020-07-13
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2020-07-13
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2020-07-13
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-07-13
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2020-07-13
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2020-07-13
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-07-13
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2020-07-13
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2020-07-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-01-17
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2020-07-13
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2020-07-13
JES	Floss, Dental	Dental	Class 1	872.6390	2020-07-13
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-07-13
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-13
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-08-13
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2020-07-13
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2020-07-13
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2024-03-28
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2020-07-13
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2020-07-13
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-07-13
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2020-07-13
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2024-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Planet Holdings Limited

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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
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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3005816808	Shummi Enterprise Co., Ltd.	Taipei, TW
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016450032. Last updated year: 2026. Please use registration number 3016450032 when referencing this establishment in official correspondence.