Manufacturer registered with FDA
Hoogland Spine Products GmbH
Unterfoehring Munich, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 13152 registrations outside the US
- Establishments
- 1Germany
Registered in 13 markets
Where regulators' registries name Hoogland Spine Products GmbH 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 | Hoogland Spine Products GmbH | 1 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Hoogland Spine Products GmbH | 46 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hoogland Spine Products GmbH | 24 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hoogland Spine Products GmbH | 23 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hoogland Spine Products GmbHHoogland Spine Products GmbH( | 22 | 2016–2023 | Pure Global AI |
| Canada | Health Canada | Registration holder | HOOGLAND SPINE PRODUCTS GMBH | 8 | 2025–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | HOOGLAND SPINE PRODUCTS GMBH | 7 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HOOGLAND SPINE PRODUCTS GMBH | 6 | 2023–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HOOGLAND SPINE PRODUCTS GMBH | 6 | 2009–2020 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HOOGLAND SPINE PRODUCTS GmbH.HOOGLAND SPINE PRODUCTS GMBH | 5 | 2021–2023 | Pure Global AI |
| China | NMPA | Registration holder | 霍格兰脊柱外科手术产品有限公司Hoogland Spine Products GmbH | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hoogland Spine Products GmbH | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Hoogland Spine Products GmbH | 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 Hoogland Spine Products GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | sealing cap | 2007 |
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 |
|---|---|---|
| Hoogland Spine Products GmbHFDA reg. 3006561161 | Unterfoehring Munich Bavaria, Germany | Foreign exporter, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023561). 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.