Brainlab
No description from the company. The catalog line you may see elsewhere is generated by us from the category and location, not a statement by the company.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Munich, Germany
- Founded
- 1989 (from our catalogue record; not confirmed by the company or by a state register)
- Website
- brainlab.com
- Categories
- 医療およびヘルスケア用品, 家電
- Markets
- ドイツ, アメリカ合衆国, 日本, 中国
What is established and what is not
No researcher review has been written for this company yet. 5 official records from 5 official sources are on file. 3 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-02. Domain registry record
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-08-23. GLEIF global LEI register (golden copy)
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-08-15. OpenSanctions
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-08-15. OpenSanctions
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 1 public contracts on record, the latest awarded 2026-08-06. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-08-06. TED (Tenders Electronic Daily), EU public procurement award notices ここでの落札は、他者による審査も伴います。EUおよびEEAでは、公共調達者は詐欺、汚職、資金洗浄で有罪となった入札者、および確定した決定で税や社会保険料の未納が認定された入札者を排除しなければなりません。 この審査はその入札の落札日時点のものです。会社の現在の状況を示すものではなく、落札は契約が履行されたことを示すものでもありません。 Directive 2014/24/EU, Article 57 (exclusion grounds)
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 50 medical devices: ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (K254010, 2026), Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K252476, 2025), Spine & Trauma Navigation Instruments (K252562, 2025) +47. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record
Claimed certifications, not confirmed by us
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
Goods family established: 医療およびヘルスケア用品 (official record of a specific product). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category 家電: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.
Check independently
Before a first order, ask for the ISO 13485, Medical Devices Quality certificate number, its holder and the products it covers.