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MESA Italia certifications and quality
Certifications · Quality · Compliance · Since 1975
Certifications and quality
MESA Italia Srl complies with the most recent quality standards and respects the strictest international criteria in the production of Class IIa and IIb medical devices, keeping its management system constantly updated in compliance with UNI CEI EN ISO 13485:2021, UNI EN ISO 9001:2015 and MDSAP (Medical Device Single Audit Program).
The quality journey
From the first ISO 9001 certification acquired by Mesa in 1996 to the MDR certification of October 2026: a continuous commitment, documented certificate by certificate.
- 1996First ISO 9001 certification — over 30 years of certified quality management
- 1998ISO 13485 certification — medical device quality
- 1996–2027Devices CE marked under Directive 93/42/EEC (MDD) — alloys, implants, components, instruments
- 2018MDSAP certification — USA/CA/JP/BR/AU
- 02/2023MDR certification — Alloys (0425-MDR-030016-00)
- 10/2026MDR certification — IGEA Implants, Components, Instruments (0425-MDR-030230-00)
The certificates
The official documents issued by the Notified Bodies and Certification Bodies, fully visible and downloadable in PDF.
EU MDR 2017/745 Certification
IGEA dental implants, Prosthetic components, Surgical instruments
Notified Body ICIM S.p.A. (No. 0425) · Certificate No. 0425-MDR-030230-00 · Class IIb implants and components, IIa instruments.
EU MDR 2017/745 Certification — Alloys
All MESA alloy lines
Notified Body ICIM S.p.A. (No. 0425) · Certificate No. 0425-MDR-030016-00 · First issue 01/02/2023.
CE Certification — Directive 93/42/EEC (MDD)
The historical European certificate, still regulatorily in force until the end of 2027
UNI CEI EN ISO 13485:2021
Medical device quality management system
ICIM · First issue 1998 · UNI CEI EN ISO 13485:2021.
UNI EN ISO 9001:2015
Quality management system
ICIM · First issue 02/08/1996 · UNI EN ISO 9001:2015.
MDSAP — Medical Device Single Audit Program
QS6-096204-0006 Rev.04
Single audit recognized by USA, Canada, Japan, Brazil and Australia. The certificate covers alloys only.
Scope of coverage
Medical devices covered by MDR 2017/745 certification and their risk class.
- IGEA dental implants — Class IIb
- Prosthetic components — Class IIb: MAGNUM HYPERONE and MAGNUM SPLENDIDUM abutments (CEM, OCA), Connection Screw (SCR), Healing Screw (HLS), Cap Screw (CPS), Multi Unit Abutment (MUA)
- Surgical instruments — Class IIa (SST)
- Dental alloys — Class IIa, all MESA lines
International registrations
Mesa is also active internationally. The Company has obtained registrations and marketing authorizations for its medical devices in numerous non-EU markets, including:
- Eastern Europe — Russia, Ukraine, Belarus
- Asia — Kazakhstan
- Maghreb — Egypt, Tunisia and Algeria
Registrations by market
Registrations by national health authority. Registrations via MDSAP cover alloys only.
FDA — United States
Food and Drug Administration registration via MDSAP
Health Canada
Canadian market registration via MDSAP
MHLW — Japan
Ministry of Health, Labour and Welfare via MDSAP
TGA — Australia
Therapeutic Goods Administration via MDSAP
ANVISA — Brazil
Agência Nacional de Vigilância Sanitária via MDSAP
Questions about certifications?
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📋 Mesa Italia Administration Contact
For requests about contracts, invoicing, registry or commercial aspects after pre-registration.
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Direct contacts
Customer Service Mesa Italia
General assistance and information
MESA Italia Customer Service is the first point of contact for requests about products, orders, catalogue and technical support. It replies in Italian and English, Monday to Friday, 8:30-17:00.
Travagliato (Brescia)
Mesa Italia S.r.l.
Production site landline
Via dell’Artigianato 35/37, 25039 Travagliato (Brescia), Italy.
+39 030 6863251