ACHB Enterprise Co.
ACHB menyediakan manufaktur presisi OEM & ODM untuk perangkat medis, instrumen ilmu hayati, dan robotika. Bersertifikasi ISO 13485, ISO
ACHB menyediakan manufaktur presisi OEM & ODM untuk perangkat medis, instrumen ilmu hayati, dan robotika. Bersertifikasi ISO 13485, ISO 9001, dan ISO 14001.
- Type
- brand seeking distribution
- Location
- Tainan City, Taiwan
- Website
- https://www.achb-tw.com/
- Categories
- Perlengkapan Medis & Kesehatan, Otomasi Industri & Robotika
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