Romaco Group GmbH
Pharma packaging and processing machinery for solid dosage forms.
Romaco Group manufactures blister packaging, tablet counting, and filling machinery for the pharmaceutical industry. The Karlsruhe-based group supplies OEM lines and complete turnkey systems to pharma manufacturers across Europe, India, and the Americas.
- Type
- Manufacturer
- Location
- Karlsruhe, Germany
- Founded
- 1985
- Website
- romaco.com
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Germany, Italy, India, United States, China
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- domain-registered (green), checked 2026-08-02 Domain registry record
- vat-valid (green), checked 2026-08-22 VIES (European Commission)
- sanctions-clear (green), checked 2026-08-16 OpenSanctions
- debarment-clear (green), checked 2026-08-16 OpenSanctions
Profiles
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
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