Zdeer Technology (Henan) Co., Ltd.
Registered establishment in Xuchang, Henan, China. 9 device types, 2 clearances.
Zdeer Technology (Henan) Co., Ltd. is a remanufacturer holding a current FDA establishment registration. The registration covers Laser, Comb, Hair, Toothbrush, Manual and 7 other device types. Its earliest product listing with the FDA dates from 2024.
9device types registered with the FDA
2510(k) clearances
Registration
| Registered name | ZDEER TECHNOLOGY (HENAN) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033905868 |
| FEI number | 3033905868 |
| Establishment type | Remanufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Xuchang |
|---|---|
| Province | Henan |
| Address | East of Wei Wu Road and south of Qin Gong East Road, Toubao Village Committee, Laotown Town, Changge |
| Postal code | 461500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Zdeer Digital Thermometer(E51151, E51152, E52151, E52152), Zdeer Infrared Thermometer(T51151, T51152, T51153, T51154, T61151, T61152, T61153, T61154, T61155, T61156), Zdeer Infrared Thermometer(T11151, T11152, T21151, T21152,T31151,T31152, T41151, T41152, T41153) | 2025 | 49 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | IN-THE-EAR Digital Hearing Aids( BS21191, BS21192, BS21193, BS21194, BS21195, BS21196, BS21197, BS21198), IN-THE-EAR Digital Hearing AIDS(BS11151, BS11152, BS11153, BS11154, BS11155, BS11156, BS11157, BS11158, BS11159,BS11160), IN-THE-EAR Digital Hearing AIDS(BS21151, BS21152, BS21153, BS21154, BS21155, BS21156, BS21157, BS21158, BS21159, BS21160, Digital Hearing AIDS(BG11171, BG11172, BG11173, BG11174, BG11175, BG11176, BG11177, BG11178, BG11179, BG11180), Digital Hearing Aids(TJ-EB135, TJ-EB211, TJ-EB212, TJ-EB213, TJ-EB221, TJ-EB222, TJ-EB223), IN-THE-EAR Digital Hearing AIDS(BS21161, BS21162, BS21163, BS21164, BS21165, BS21166, BS21167, BS21168, BS21169, BS21170 and 9 more | 2025 | 52 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | ZD-ZT-BS0129,ZD-ZT-BS0130,ZD-ZT-BS0131,ZD-ZT-BS0132,ZD-ZT-BS0133,ZD-ZT-BS0134,ZD-ZT-BS0135, ZD-ZT-BG0125,ZD-ZT-BG0126,ZD-ZT-BG0127,ZD-ZT-BG0128,ZD-ZT-BG0129,ZD-ZT-BG0130, ZD-T0604YN,ZD-ZT6N,ZD-ZT7N,ZD-ZT8N,ZD-ZT9N,ZD-ZT10N,ZD-ZT11N,ZD-ZT12N,ZD-ZT13N, ZD-T0201YN,ZD-T0501YN,ZD-T0502YN,ZD-T0601YN,ZD-T0602YN,ZD-T0603YN, ZD-ZT-BG0131,ZD-ZT-BG0132,ZD-ZT-BG0133,ZD-ZT-BG0134,ZD-ZT-BG0135,ZD-ZT-BG0136, ZD-ZT-BS0105,ZD-ZT-BS0106,ZD-ZT-BS0107,ZD-ZT-BS0108,ZD-ZT-BS0109,ZD-ZT-BS0110 and 13 more | 2024 | 57 |
| Hearing Aid, Bone Conduction | Class 2 | Bone Conduction Hearing Aid (G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160), Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155), Bone Conduction Hearing Aid (G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155), Bone Conduction Hearing Aid (G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | 2026 | 4 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | Class 1 | Smart Oralfreshener Spray; PW15, PW16, PW17, PW18, PW13 | 2025 | 55 |
| Laser, Comb, Hair | Class 2 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | 2026 | 30 |
| Massager, Therapeutic, Electric | Class 1 | 2025 | 437 | |
| Toothbrush, Manual | Class 1 | LuxeArt Toothbrush:ZD-D201.ZD-D202.ZD-D203, ARTISTIC TOOTHBRUSH; ZD-D401-Matte Finish Version | 2025 | 244 |
| Toothbrush, Powered | Class 1 | vibrating electric toothbrush; ZD-S4, ZD-S3, ZD-S2, ZD-S1, ZD-HS5 | 2024 | 191 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260899 | 2026-06-16 | OAP | Traditional | This company |
| K260452 | 2026-06-15 | LXB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Employees | 200 |
| Main products | oral care devices, nasal care products, massage devices, hearing aids |
| Export markets | United States, international |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Xuchang Zhengde Environstar Medical Products Co., Ltd. | 7 |
| Xuchang Zhende Surgical Dressing Co., Ltd. | 6 |
| Henan Zhende Medical Products Co., Ltd. | 5 |
| Yanling Medtech Medical Products Co., Ltd. | 3 |
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.