Manufacturer registered with FDA
Beijing Biosis Healing Biological Technology Co., Ltd
Beijing, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12024–2024
- Markets registered in
- 626 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Beijing Biosis Healing Biological 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 | Beijing Biosis Healing Biological Technology Co., Ltd | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | Beijing Biosis Healing Biological Technology Co., Ltd. | 15 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Beijing Biosis Healing Biological Technology Co Ltd | 1 | 2021–2021 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Beijing Biosis Healing Biological Technology Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Beijing Biosis Healing Biological Technology Co., Ltd | 1 | — | 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 Beijing Biosis Healing Biological 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 |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | Oral Matrix | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Beijing Biosis Healing Biological Technology Co., Ltd as the applicant.
Some of these clearances are listed with FDA today by another company: Ritter Implants GmbH and Co. KG (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTDFDA reg. 3016668451 | Beijing, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062854). 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.