Heaven Healthcare Co., Ltd.
Registered establishment in Shaoxing, Zhejiang, China. 33 device types.
Heaven Healthcare Co., Ltd. is a private-label distributor holding a current FDA establishment registration. The registration covers Bedpan, Bag, Ice and 31 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012034017 |
| FEI number | 3012034017 |
| Establishment type | Private-label distributor, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 天堂醫療用品有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Shaoxing |
|---|---|
| Province | Zhejiang |
| Address | Room 1905,Xingyuan Int’l Bldg, |
| Postal code | 312000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Non-woven Swabs | 2016 | 186 |
| Bag, Drainage, With Adhesive, Ostomy | Class 1 | Urostomy Bag, Ostomy Bag | 2023 | 49 |
| Bag, Ice | Class 1 | Ice Pack | 2019 | 86 |
| Bandage, Elastic | Class 1 | Medical Bandage, Cohesive Bandage | 2016 | 280 |
| Basin, Emesis | Class 1 | Vomit Bag, Emesis Bag | 2025 | 65 |
| Bedding, Disposable, Medical | Class 1 | Emergency blanket, Biodegradable Body Bag, Body Bag | 2018 | 308 |
| Bedpan | Class 1 | Commode Liner, Toilet Bowl Liner | 2023 | 34 |
| Cap, Surgical | Class 1 | Non-woven Cap | 2017 | 178 |
| Disinfectant, Medical Devices | Class 1 | Cleansing Wipes | 2019 | 197 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Hydrogel Dressing | 2024 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Wound Dressing,Alginate Dressing, Hydrocolloid Dressing, Acne Patch, Island dressing, Hydrocolloid Pimple Patch, Blister Plaster and 1 more | 2016 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Foam Dressing, Non-adherent Dressing,Adhesive Dressing Plaster, Silicone Foam Dressing, Silicone Wound Contact Dressing, Chest Seal, Vaseline Gauze and 3 more | 2016 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Gel Scar Dressing, Silicone Scar Sheet | 2016 | 85 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask, Surgical Mask | 2020 | 182 |
| First Aid Kit With Drug | Class N | First Aid Kit With Drug | 2023 | 57 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit, CPR Mask Keychain | 2018 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Medical Gauze Sponge, dry prep sponge stick, Burn Dressing, Chitosan Hemostiatic Gauze, Kaolin Hemostatic Gauze | 2016 | 266 |
| Gown, Examination | Class 1 | Lab Coat | 2023 | 109 |
| Mask, Oxygen | Class 1 | CPR Face Shield, CPR Resuscitator, CPR Mask | 2023 | 126 |
| Medical Glove, Specialty | Class 1 | 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 | 2024 | 48 |
| Mouthpiece, Breathing | Class 1 | Anti Snore Mouth Piece/Snoring Stopper/Anti Snoring Device | 2024 | 67 |
| Non-Surgical Gown | Class 1 | Isolation gown | 2020 | 318 |
| Pack, Hot Or Cold, Disposable | Class 1 | Hot Cold Pack, Medical Heat Patch | 2019 | 176 |
| Polymer Patient Examination Glove | Class 1 | 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, Powder Free Nitrile Patient Examination Gloves | 2024 | 83 |
| Protector, Ostomy | Class 1 | Barrier Ring, Barrier Strip | 2020 | 33 |
| Scissors, Medical, Disposable | Class 1 | Bandage Scissor | 2023 | 36 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | Splinter Probes | 2019 | 36 |
| Solvent, Adhesive Tape | Class 1 | Adhesive Remover, Ostomy Adhesive Remover | 2021 | 20 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | Foam Splint | 2023 | 62 |
| Tape And Bandage, Adhesive | Class 1 | Medical Tape,Wound Closure Strip, Motion Sickness Patch, Shower Protector | 2016 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2017 | 124 |
| Unit, Operative Dental, Accessories | Class 1 | Universal Barrier Film | 2023 | 65 |
| Valve, Non-Rebreathing | Class 2 | Non-Rebreathing Valve (18.5mm), Non-Rebreathing Valve (15mmOD), Infant CPR Mask with Oxygen Port, CPR Resuscitator, CPR Mask, CPR Mask with Oxygen Port and 1 more | 2024 | 19 |
Clearances
No clearance names Heaven Healthcare Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200093 | 2020-08-20 | LZA | Traditional | Anhui Lntco Medical Products Co., Ltd. |
| K171961 | 2017-11-17 | CBP | Traditional | Xiamen Compower Medical Tech. Co., Ltd. |
| K121526 | 2012-08-03 | LZA | Traditional | Shandong Junchi Medical Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | First aid products, Medical products, Healthcare products |
|---|
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.