ACHB Enterprise Co.
ACHB, tıbbi cihazlar, yaşam bilimi aletleri ve robotik için OEM ve ODM hassas üretim sağlar. ISO 13485, ISO 9001 ve ISO 14001
ACHB, tıbbi cihazlar, yaşam bilimi aletleri ve robotik için OEM ve ODM hassas üretim sağlar. ISO 13485, ISO 9001 ve ISO 14001 sertifikalıdır.
- Type
- brand seeking distribution
- Location
- Tainan City, Taiwan
- Website
- https://www.achb-tw.com/
- Categories
- Tıbbi ve Sağlık Malzemeleri, Endüstriyel Otomasyon ve Robotik
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