Shenzhen WAP-Health Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 16 device types, 2 products catalogued.
Shenzhen WAP-Health Technology Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Mask, Oxygen, Bandage, Cast and 14 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | SHENZHEN WAP-HEALTH TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011647251 |
| FEI number | 3011647251 |
| DUNS | 544582165 |
| Establishment type | Repacker / relabeller, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 3, Building C, The Third Industrial Zone #23, Gongming |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Cast | Class 1 | Bandage | 2020 | 81 |
| Bandage, Elastic | Class 1 | Bandage | 2020 | 280 |
| Cabinet, Instrument, Ac-Powered, Ophthalmic | Class 1 | 2019 | 1 | |
| Cabinet, Table And Tray, Anesthesia | Class 1 | Cabinet | 2025 | 22 |
| Cpr Aid Device Without Feedback | Class 1 | 2024 | 5 | |
| Dressing, Wound, Hydrophilic | Class 1 | 2020 | 195 | |
| First Aid Kit Without Drug | Class 1 | 2024 | 132 | |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | 2020 | 266 | |
| Hearing Aid, Group And Auditory Trainer | Class 2 | Hearing aid | 2022 | 1 |
| Kit, First Aid, Talking | Class 1 | 2019 | 18 | |
| Mask, Oxygen | Class 1 | 2020 | 126 | |
| Mouthpiece, Breathing | Class 1 | Cabinet, WAP-health | 2020 | 67 |
| Polymer Patient Examination Glove | Class 1 | 2024 | 83 | |
| Scissors, Medical, Disposable | Class 1 | 2020 | 36 | |
| Splint, Temporary Training | Class 1 | Splint | 2022 | 16 |
| Valve, Non-Rebreathing | Class 2 | Valve | 2024 | 19 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| First Aid Kit Without Drug | OHO | 1 |
| WAP | OVR | 1 |
Clearances
No clearance names Shenzhen WAP-Health Technology Co., Ltd. as applicant. 2 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 |
|---|---|---|---|---|
| K231408 | 2023-08-11 | LZA | Traditional | Shandong Intco Medical Products Co Ltd |
| K171961 | 2017-11-17 | CBP | Traditional | Xiamen Compower Medical Tech. Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | AED cabinets, AED trainers, CPR training equipment, First aid kits, Bleeding control kits |
| Certifications | CE, TUV, SGS, FDA, ISO |
| Export markets | 200 countries |
| OEM and ODM | Offered |
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.