Registered with FDA
Hangzhou HaiZhu MIM products Co., Ltd
Hangzhou, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Hangzhou HaiZhu MIM products 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 | Lister | Hangzhou HaiZhu MIM products Co., Ltd | 7 device types | — | Below |
| Brazil | ANVISA | Manufacturer | HANGZHOU HAIZHU MIM PRODUCTS CO., LTD. | 1 | 2026–2026 | 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 Hangzhou HaiZhu MIM products 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | MOUTH MIRROR | 2019 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Lister | Ortho plier | 2022 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | Bracket | 2022 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | Cotton and Dressing Tweezers; splinter tweezers Forceps; Dressing forceps | 2018 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | RETRACTOR | 2020 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | Porbe | 2019 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Lister | extracting forceps, bone rongeur, tooth elevators, mouth mirror, tweezers, explorers, curette, periodontal probesretractors, clamps forceps | 2021 |
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 |
|---|---|---|
| HANGZHOU HAIZHU MIM PRODUCTS CO., LTDFDA reg. 3011585752 | Hangzhou Zhejiang, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058657). 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.