Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012034017

FEI Number

3012034017

Entity Name

Heaven Healthcare Co., Ltd.

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

Room 1905,Xingyuan Int'l Bldg,, Yuecheng District,Shaoxing,China, Shaoxing Zhejiang 312000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Heaven Healthcare Co., Ltd. (Owner Number: 10050953)

Owner / Operator Contact Address

Room 1905,Xingyuan Int'l Bldg,, Yuecheng District,Shaoxing,China, Shaoxing, CN-ZJ 312000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cleansing Wipes Bandage Scissor Tourniquet Non-adherent Dressing,Adhesive Dressing Plaster Silicone Foam Dressing Vaseline Gauze Silicone Wound Contact Dressing Chest Seal Oil Emulsion Dressing Honey Gauze Dressing Foam Dressing Super Absorbency Dressing Universal Barrier Film Hot Cold Pack Medical Heat Patch Non-woven Cap Emergency blanket Biodegradable Body Bag Body Bag Barrier Ring Barrier Strip First Aid Kit, CPR Mask Keychain Powder Free Nitrile Patient Examination Gloves Lab Coat Adhesive Remover, Ostomy Adhesive Remover Medical Gauze Sponge dry prep sponge stick Burn Dressing Chitosan Hemostiatic Gauze Kaolin Hemostatic Gauze Nitrile Exam Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs Medical Bandage CPR Mask with Oxygen Port Non-Rebreathing Valve (18.5mm) Infant CPR Mask with Oxygen Port Non-Rebreathing Valve (15mmOD) CPR Mask without Oxygen Port CPR Resuscitator CPR Mask Wound Dressing,Alginate Dressing Hydrocolloid Dressing Hydrocolloid Pimple Patch Island dressing Acne Patch Blister Bandage Blister Plaster Silicone Gel Scar Dressing Silicone Scar Sheet Splinter Probes Emesis Bag Vomit Bag CPR Face Shield CPR Mask CPR Resuscitator Ostomy Bag Urostomy Bag Ice Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2019-10-23
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2023-10-19
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2017-12-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-01-20
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2023-05-24
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2019-10-23
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2017-12-14
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2018-12-20
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-05-26
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-12-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-11-15
FME	Gown, Examination	General Hospital	Class 1	880.6265	2023-10-19
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2021-09-24
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-01-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-11-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-11-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-01-20
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2024-11-14
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-01-20
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2016-01-20
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-10-23
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2025-07-23
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-10-19
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2023-10-19
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2019-10-23

Official Correspondent

Jun Yu

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Heaven Healthcare Co., Ltd.

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012034017. Last updated year: 2026. Please use registration number 3012034017 when referencing this establishment in official correspondence.