Manufacturer registered with FDA
Hubei Lanbin Medical Group Co., Ltd.
Xiaogan City, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 589 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Hubei Lanbin Medical Group 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 | Hubei Lanbin Medical Group Co., Ltd. | 6 device types | — | Below |
| European Union | EUDAMED | Registration holder | Hubei Lanbin Medical Group Co., Ltd. | 66 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hubei Lanbin Medical Group Co., Ltd. | 17 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hubei Lanbin Medical Group Co Ltd | 3 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HUBEI LANBIN MEDICAL GROUP CO., LTD. | 3 | 2024–2025 | 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 Hubei Lanbin Medical Group 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 | Maker | MIRROR, MOUTH | 2022 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | FORCEPS, DRESSING, DENTAL | 2022 |
| Roll CottonEFN · Class 1 | — | Maker | Sterile cotton balls | 2024 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Lister | EXCAVATOR, DENTAL, OPERATIVE | 2022 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | General Purpose Dental Tray - General Purpose Dental Tray | 2022 |
| Oral Surgery TrayPWL · Class 1 | Dental hand instruments | Maker | Oral Surgery Tray - Oral Surgery Tray | 2022 |
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 |
|---|---|---|
| Hubei Lanbin Medical Group Co., Ltd.FDA reg. 3014257280 | Xiaogan City Hubei, China | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10074049). 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.