ERWEKA GmbH
Pharmaceutical testing instruments for tablets and dosage forms.
ERWEKA manufactures pharmaceutical testing instruments including dissolution testers, disintegration testers, tablet hardness testers, and powder flow instruments for quality control and R&D. The Heusenstamm company exports USP/EP-compliant pharma test instruments to QC laboratories worldwide.
- Type
- Manufacturer
- Location
- Heusenstamm, Germany
- Founded
- 1951
- Website
- erweka.com
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Germany, United States, Japan, China, United Kingdom
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- sanctions-clear (green), checked 2026-08-16 OpenSanctions
- debarment-clear (green), checked 2026-08-16 OpenSanctions
- public-contract-awarded (green), checked 2024-07-25 TED (Tenders Electronic Daily), EU public procurement award notices Here the award carries someone else's check: in the EU and the EEA a public buyer must exclude bidders convicted of fraud, corruption or money laundering, and those found by a final decision to owe taxes or social contributions. Directive 2014/24/EU, Article 57 (exclusion grounds)
- vat-valid (green), checked 2026-08-18 VIES (European Commission)
- aeo-certified (green), checked 2026-08-16 EU AEO register (European Commission)
Profiles
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- AEO, Authorised Economic Operator EU AEO database
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