Manufacturer registered with FDA
Nicefeel Medical Device Technology Co.,Ltd.
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 19
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Nicefeel Medical Device Technology Co.,Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Nicefeel Medical Device Technology Co.,Ltd. | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Nicefeel medical Device Technology Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Nicefeel Medical Device Technology Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | coolean,CL-501,FC169; Cremax,CM-PCA001,FC1592; DOCSMEDI,TB5011SET(TB5011+TB5011-C),FC1596;FLOOVER FC5091, FL-01HULMAY FC5170, P1, P1 PLUS, P2, P2 PLUSMAYSEN,FC1591; medica+,Prowater Station 7,FC162,Prowater Clean 7,FC259; MEYARN,MY-M-007,FC1596,MY-M06-S1,FC2662;Nicefeel FC175, FC176, FC3921, FC3832, FC5170, FC3841;Nicefeel FC3830, FC1581, FC3880, FC5090, FC5091, FC5080, FC3980, FC3940, FC3950, FC3960, FC188, FC3680, FC3810, FC5120;Nicefeel FC5200, FC5360, FC180, FC1751, FC1761, FC5210, FC163-A, FC5230, FC5240, FC5260FC5092Nicefeel,FC1596,FC3840,FC3920,FC1522,FC2630; Nicefeel,FC188,FC3680,FC3810;OraTec FC3680, VJ03Sawgmore FC180, FC180 7 moreSawgmore FC5360, FC5360SEJOY FC5091, FC5091SEJOY FC5240, FC5240SoundAI FC5260, SAI-SDA610, SAI-SDA611truefloss FC5090, TF-1TUREWELL FC180, FC180TUREWELL FC5360, FC5360 | 2020 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | FC2610,FC2660,2661,FC2690,FC2700,FC2720,FC2730,FC3810,FC3820,FC3830,FC3840,FC3850,FC3860,FC3870,FC3880,FC3890,FC158;Nicefeel,FC168,FC259,FC2520,FC188,FC256,FC2680,FC188G,FC152,FC2581,FC158,FC2550,FC2550,FC169,FC2580; | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NICEFEEL MEDICAL DEVICE TECHNOLOGY CO.,LTD.FDA reg. 3015516536 | SHENZHEN Guangdong, China | Complaint file establishment, Contract manufacturer, Contract sterilizer, Foreign exporter, Manufacturer, Private-label distributor, Remanufacturer, Repacker / relabeler, Reprocessor, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060942). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.