APEX BIOTECHNOLOGY CORP.
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
- HSINCHU, Taiwan
- Categories
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 11 official records from 7 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
- 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)
- Legally registered and still active (record type: registry-active-global) [official record; status green] Shows the register lists the registration as active on the date we read it. It does not show how busy the business is. checked 2026-10-17. Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- A change to the company's registration was published on the official record (record type: registry-change-published) [official record; status green] Indicates the register still receives filings from this company, so the record is maintained rather than abandoned. checked 2026-10-17. Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- A director was appointed, on the official record (record type: officer-appointed) [official record; status green] Shows that a named person answers for the company on the public record. checked 2026-10-17. Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- Owners named in the company register (record type: ownership-on-record) [official record; status green] Names the company's owners or controllers as the register records them. checked 2026-10-17. Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 26 medical devices: UASure II Blood Uric Acid Monitoring System (K242209, 2025-04-04), GlucoSure Link Blood Glucose Monitoring System (K212140, 2022-08-25), MTM301 Blood Glucose and Ketone Monitoring System (K202534, 2022-04-06) +23. 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)
- 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 2026-08-07. US FDA device establishment registration (openFDA)
- Line of business as recorded in the state register: 其他醫療器材及用品製造 (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
- 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 2026-09-02. 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 2026-09-02. 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 2026-09-02. FDA
Relationships
1 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
- 三陽工業股份有限公司: Legal entity on the board. Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
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)