Baui Biotech Co., Ltd
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
A ANVISA, órgão regulador sanitário brasileiro, possui um certificado de Boas Práticas de Fabricação válido para esta planta, abrangendo dispositivos médicos, válido até 02/09/2026. O certificado é emitido após inspeção na própria fábrica, por isso um órgão regulador estrangeiro batiza este site: produtos fabricados aqui são permitidos no mercado brasileiro. O certificado registra o endereço do site como Nº 6 (6F), Nº 8 (6F, 9F), SEC. 1, ZHONGXING RD., DISTRITO DE WUGU, NOVA CIDADE DE TAIPEI, 24872 - TAIWAN. Número do processo 25351562714201571.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Xinbei (New Taipei City), Taiwan
- Categories
- Suprimentos médicos e de saúde
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 7 official records from 6 official sources are on file. 2 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
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-08-21. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-10-16. Taiwan Industrial Development Administration, registered factory directory (status: producing)
- 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 2026-10-16. Taiwan International Trade Administration, import/export firm registry (BOFT)
- Registered with the state to export across borders (record type: export-registered) [official record; status green] A state or statutory export body lists this company as a registered exporter. It shows the registration, not that any shipment took place or that a particular product may be exported. checked 2026-10-16. Taiwan International Trade Administration, import/export firm registry (BOFT)
- Line of business as recorded in the state register: 其他藥品及醫療用品批發 (record type: registry-activity) [official record; status green] Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-10-16. Taiwan Ministry of Finance, national business tax registration
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 5 medical devices: NOVA Minimally Invasive System (K242899, 2024-10-17), COMET Lumbar Interbody Fusion Cage (K191353, 2020-04-14), Facilis Spinal System (K191494, 2019-08-12) +2. 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)
- 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 2026-08-31. OpenSanctions
- 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 2026-08-31. OpenSanctions
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-31. FDA
Relationships
2 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Recorded in a source
- 65002562: Site named in the record, registry number 65002562. Taiwan Industrial Development Administration, registered factory directory (status: producing)
- Nº 6 (6F), Nº 8 (6F, 9F), SEC. 1, ZHONGXING RD., WUGU DISTRICT, NEW TAIPEI CITY, 24872 - TAIWAN: Manufactures at the site. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
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)