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Heaven Healthcare Co., Ltd.: FDA-registered device maker in Shaoxing Zhejiang, China, 3 510(k) clearances

Name: Heaven Healthcare Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Heaven Healthcare Co., Ltd. is registered with the FDA (registration 3012034017) in Shaoxing Zhejiang, China. It lists 33 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 20, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012034017
Address: Room 1905,Xingyuan Int'l Bldg, Yuecheng District,Shaoxing,China, Shaoxing Zhejiang, China, 312000
Owner or operator: Heaven Healthcare Co., Ltd. (10050953)
Roles: Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: January 20, 2016
Registered through: 2027
Brand names listed: Acne Patch, Adhesive Remover, Ostomy Adhesive Remover, Anti Snore Mouth Piece/Snoring Stopper/Anti Snoring Device, Bandage Scissor, Barrier Ring, Barrier Strip, Biodegradable Body Bag, Blister Bandage and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Manufacturer	accessdata.fda.gov
Bag, Ice	KYR	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Bedpan	FOB	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Manufacturer	accessdata.fda.gov
First Aid Kit With Drug	LRR	N	Manufacturer	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US, Foreign private label distributor	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US, Foreign private label distributor	accessdata.fda.gov
Protector, Ostomy	EXE	1	Manufacturer	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Manufacturer	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Manufacturer	accessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-Sterile	NOC	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Exporter to the US, Foreign private label distributor	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 20, 2020	K200093	Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug	LZA	Substantially Equivalent	Anhui Lntco 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
August 3, 2012	K121526	POWER-FREE NITRILE PATIENT EXAMINATION GLOVES	LZA	Substantially Equivalent	Shandong Junchi Medical Products Co., Ltd.	accessdata.fda.gov

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Updated August 20, 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.