CERTIFICATES

Certificates

TÜV Rheinland LGA Product GmbH - Certificate on Quality Management, Scope:

Design/development, production, distribution, installation and services of low temperature ethylene oxide sterilizers. 
Contract sterilization by ethylene oxide according to EN ISO 11135:2014
DMB Apparatebau GmbH, EN ISO 13485:2016, valid until 2025/07/12

TÜV Rheinland LGA Product GmbH - EC Certificate, Scope:

Directive 93/42/EEC Annex II, excluding Section 4
DMB Apparatebau GmbH, Certificate, valid until 2024/05/26

Landesamt Rheinland-Pfalz - GMP Pharma:
Manufacturer's Authorisation, § 13 para 1 Arzneimittelgesetz (German Drug Law)
DMB Apparatebau GmbH certificate , date 31.08.2017


International Certificates:
 Registration Number: 3005465238

Certificate Medical Device Manufatorer (Japan), Act of Pharmaceutical and Medical Devices, § 23-2-4
 Japanese ministry of hea lth, valid until 2026

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