Dongguan Simzo Electronic Technology Co., Ltd.
Manufacturer and brand owner in Dongguan, Guangdong, China. 4 device types, 46 products catalogued, 3 clearances.
Dongguan Simzo Electronic Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Clinical Electronic Thermometer, Continuous Measurement Thermometer and 2 other device types. 46 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
4device types registered with the FDA
46products catalogued under its own name
3510(k) clearances
Registration
| Registered name | DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015142935 |
| FEI number | 3015142935 |
| DUNS | 544332470 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 东莞市兴洲电子科技有限公司 |
|---|---|
| Unified social credit code | 91441900576434450G |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | No.6, Zhangzhou Road, Daojiao Town, |
| Postal code | 523187 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Infrared Forehead Thermometer HW-F1, HW-F2, HW-F3, HW-F4, HW-F5, HW-F6, HW-F7, HW-F8, HW-B05;, Infrared Thermometer HW-E01, HW-E02, HW-E03, HW-E04;, clinical electronic thermometer TH-801, TH-802, TH-803, TH-804 | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer, HW-1, Non-contact Forehead Thermometer, HW-2, HW-2S, HW-3, HW-4, HW-4S, HW-302, HW-303 | 2018 | 115 |
| Nebulizer (Direct Patient Interface) | Class 2 | Portable (Ultrasonic) Nebulizer; Portable Mesh Nebulizer; Portable Nebulizer; Mesh Nebulizer, NBM-1, NBM-2, NBM-3, NBM-4, NBM-5, NBM-6, NBM-7, NBM-8, NBM-9, NBM-10, NBM-11, NBM-3B, NBM-4B, NBM-5B, NBM-6B, NBM-7B, NBM-8B, NBM-9B, NBM-21B, NBM-10N | 2023 | 42 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | NBM-3BC, NBM-4BC, NBM-5BC, NBM-6BC, NBM-7BC, NBM-8BC, NBM-9BC, NBM-1C, NBM-2C, NBM-3C, NBM-4C, NBM-5C, NBM-6C, NBM-7C, NBM-8C, NBM-9C, NBM-10C, NBM-11C, Nebulizer | 2024 | 57 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Simzo | FLL | 26 |
| Nebulizer (Direct Patient Interface) | CAF | 3 |
| SRBCare | CAF | 2 |
| Airpulse | CAF | 2 |
| Sunbeam | FLL | 2 |
| sucete | FLL | 1 |
| Vpayi | FLL | 1 |
| BLScode | FLL | 1 |
| Halidodo | FLL | 1 |
| Bionso | FLL | 1 |
| Wishdream | FLL | 1 |
| ChiSip | FLL | 1 |
| WilBee | FLL | 1 |
| wwdoll | FLL | 1 |
| Bcbpot | FLL | 1 |
| Vibeey | FLL | 1 |
| Alphamed | CAF | 1 |
| Fanle | FLL | 1 |
| Prexiso | FLL | 1 |
| eZthings | FLL | 1 |
| firhealth | FLL | 1 |
| Idoit | FLL | 1 |
| Huheta | FLL | 1 |
| Blue JAY | FLL | 1 |
| Yuikio | FLL | 1 |
| Hotodeal | FLL | 1 |
| Aoeom | FLL | 1 |
| Breathe Pure | FLL | 1 |
| konjac | FLL | 1 |
| Ahotop | FLL | 1 |
| shecare | FLL | 1 |
| MAMi&BABi | FLL | 1 |
| Balnore | CAF | 1 |
| Anthsania | CAF | 1 |
| Xrgo | FLL | 1 |
| Aluratek | FLL | 1 |
| XDX | FLL | 1 |
| Comfort Zone Clean | FLL | 1 |
| KKmier | FLL | 1 |
| Goldblatt | FLL | 1 |
| Victor | FLL | 1 |
| Quanji | FLL | 1 |
| Ralimi | CAF | 1 |
| CadeVita | CAF | 1 |
| Harton | CAF | 1 |
| Moes | FLL | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230379 | 2023-11-27 | CAF | Traditional | This company |
| K211583 | 2021-09-03 | FLL | Traditional | This company |
| K173048 | 2018-12-06 | FLL | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Employees | 300 |
| Factory area | 10000 square meters |
| Main products | medical mesh nebulizer, infrared thermometers, electronic thermometers, electric spray nose washer |
| Certifications | ISO 13485, CE, FDA, MDD |
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.