ACHB Enterprise Co.
ACHB fournit une fabrication de précision OEM et ODM pour les dispositifs médicaux, les instruments des sciences de la vie et la robotique
ACHB fournit une fabrication de précision OEM et ODM pour les dispositifs médicaux, les instruments des sciences de la vie et la robotique. Certifié ISO 13485, ISO 9001 et ISO 14001.
- Type
- brand seeking distribution
- Location
- Tainan City, Taiwan
- Website
- https://www.achb-tw.com/
- Categories
- Fournitures médicales et de santé, Automatisation industrielle et robotique
Listed in a source registry
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- domain-registered (green), checked 2026-08-03 Domain registry record
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- fda-registered (green), checked 2026-08-03 FDA
- fda-contract-manufacturer (green), checked 2026-08-03 FDA
- debarment-clear (green), checked 2026-08-03 OpenSanctions
- market-access-us (green), checked 2026-08-23 FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
- registry-active-global (green), checked 2026-08-20 Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- registry-change-published (green), checked 2026-08-20 Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- officer-appointed (green), checked 2026-08-20 Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- facility-registered (green), checked 2026-08-14 Taiwan Industrial Development Administration, registered factory directory (status: producing)
- registry-id-verified (green), checked 2026-08-14 Taiwan International Trade Administration, import/export firm registry (BOFT)
- export-registered (green), checked 2026-08-14 Taiwan International Trade Administration, import/export firm registry (BOFT)
- registry-activity (green), checked 2026-08-14 Taiwan Ministry of Finance, national business tax registration
Claimed certifications
- FDA Registered FDA Establishment Registration
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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission