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Certificato UE del Sistema di Gestione della Qualità EU Quality Management System Certificate
Certificato UE del Sistema di Gestione della Qualità EU Quality Management System Certificate
Certificate Overview
This document is the EU Quality Management System Certificate (No. 0425-MDR-030138-00) issued by ICIM S.p.A., a notified body (ID 0425), in accordance with Annex IX Chapters I and III of EU Regulation 2017/745. The certificate confirms that the quality management system implemented by Dial Medicali S.R.L. complies with the regulatory requirements for sterile external fixators used in traumatology and orthopaedics.
The certificate is valid from 15 July 2025 until 14 July 2030, subject to ongoing surveillance by ICIM as per Annex XII of the Regulation. The scope of the quality system audit is limited to aspects defined in Article 52(7) of the Regulation.
Manufacturer and Locations
- Manufacturer: Dial Medicali S.R.L.
- Head Office: Via Libero Temolo, 4, 20126 Milano, Italy
- Operative Unit: Viale Lombardia, 6, 20092 Cinisello Balsamo, Italy
- Single Registration Number: IT-MF-000031598
Product Scope and Compliance
The certificate covers the products, processes, and services listed in the attached annex, specifically sterile external fixators for traumatology and orthopaedics. The certificate is valid only when accompanied by the annex detailing the product models and types.
Device Identification and Classification
The annex provides detailed identification codes, classifications, and specifications for various device groups manufactured by Dial Medicali S.R.L. All device codes are registered with ICIM and require notified body approval for any new code assignment.
Device Groups and Key Parameters
- T-Fix/FixUp/eFix (Single-sided fixators): Codes 02-11XXX, 02-5900XX, 02-8YXXX, 02-81XXX, 02-99XXX. Diameter ranges from 1 to 15 mm; lengths vary between 30 and 80 mm for fixators and up to 700 mm for carbon bars.
- RailFix (Fixator to track): Codes 03-040XXX (carbon), 03-600XXX (aluminum), 03-1364XX (dynamizer). Lengths range from 20 to 500 mm.
- IFIX in Aluminium (Radial esopodal fixator): Codes 04-XXXX, 04-XXXXX, 04-9XXXXX. Ring diameters between 80 and 280 mm; element lengths 50 to 400 mm; actuator diameters 20 to 300 mm.
- Surgical Tools: Codes 05-08XXXX for steel drills with diameters 1.5 to 7 mm and lengths 110 to 350 mm.
- RRS (Radial circular fixator): Codes 06-XXXXX. Element diameters 80 to 280 mm; lengths 10 to 300 mm.
- IFIX in Carbon (Radial esopodal fixator): Codes 07-XXXXX. Ring diameters 80 to 280 mm.
Conditions and Limitations
The certificate’s validity depends on continuous surveillance by the notified body and adherence to the quality management system requirements. The notified body’s involvement is limited to the scope defined by Article 52(7.a) of the EU Regulation.
All device codes are controlled and must be authorized by the notified body before assignment to ensure traceability and regulatory compliance.
Summary of Critical Information
- Certificate Number: 0425-MDR-030138-00
- Issuing Body: ICIM S.p.A. (Notified Body 0425)
- Manufacturer: Dial Medicali S.R.L.
- Scope: Sterile external fixators for traumatology and orthopaedics
- Validity: 15 July 2025 to 14 July 2030
- Compliance: EU Regulation 2017/745 Annex IX Chapters I and III
- Device Codes: Detailed classification with diameter and length parameters for each device group
- Surveillance: Ongoing per Annex XII of EU Regulation 2017/745
- Limitations: Audit scope limited to Article 52(7) aspects; new device codes require notified body approval
Catalog excerpts
Certificato UE del Sistema di Gestione della Qualità EU Quality Management System Certificate Certificato N. Certificate No. 0425-MDR-030138-00 Secondo l’Allegato IX Capo I e III del Regolamento UE 2017/745 According to Annex IX Chapter I and III of EU Regulation 2017/745 ORGANISMO NOTIFICATO / NOTIFIED BODY ICIM S.p.A. - Identification number: 0425 Piazza Don Enrico Mapelli, 75 - 20099 Sesto San Giovanni (MI) - ITALY VISTO L’ESITO DELLE VERIFICHE CONDOTTE IN CONFORMITÀ ALL’ALLEGATO IX CAPO I E III DEL REGOLAMENTO UE 2017/745 DICHIARA CHE IL SISTEMA DI GESTIONE DELLA QUALITÀ ATTUATO DA: ON THE BASIS OF THE ASSESSMENT PERFORMED ACCORDING TO ANNEX IX CHAPTER I AND III OF EU REGULATION 2017/745 DECLARES THAT THE QUALITY MANAGEMENT SYSTEM ENFORCED BY: DIAL MEDICALI S.R.L. SEDE LEGALE/ HEAD OFFICE VIA LIBERO TEMOLO, 4 20126 MILANO MI IT - Italia UNITÀ OPERATIVA / OPERATIVE UNIT VIALE LOMBARDIA, 6 20092 CINISELLO BALSAMO MI IT - Italia Numero di Registrazione / Single Registration Number: IT-MF-000031598 PER I PRODOTTI, PROCESSI, SERVIZI RIPORTATI NELL’ALLEGATO FOR THE PRODUCTS, PROCESSES, SERVICES LISTED IN THE ATTACHED ANNEX FISSATORI ESTERNI STERILI PER TRAUMATOLOGIA ED ORTOPEDIA STERILE EXTERNAL FIXATORS FOR TRAUMATOLOGY AND ORTHOPAEDICS È CONFORME AI REQUISITI / IS IN COMPLIANCE WITH REQUIREMENTS Allegato IX Capo I e III del Regolamento UE 2017/745 Annex IX Chapter I and III of EU Regulation 2017/745 Per l’identificazione dei modelli di prodotto vedere l’Allegato / For identification of the model type see Annex Il presente Certificato è da ritenersi valido solo se accompagnato dal relativo Allegato / This Certificate is valid only with the relative Annex La validità del presente certificato è subordinata alle attività di sorveglianza da parte dell’organismo notificato in conformità all’Allegato XII del Regolamento UE 2017/745 The validity of this certificate is subject to the surveillance activities by the notified body according to Annex XII of EU Regulation 2017/745 L’audit di valutazione del sistema di gestione della qualità è limitato agli aspetti previsti dall’articolo 52, paragrafo 7 The quality management system audit is limited to the aspects required pursuant to Article 52 (7) Storicità del Certificato / Certificate History Certificato precedente / Previous certificate Data di rilascio / Issue date Modifiche apportate / Changes Test effettuati, riferimenti normativi e rapporti Tests, standards references and reports Informazioni sulla sorveglianza da parte dell’organismo notificato (se applicabile) Information about the surveillance by the notified body (if applicable) Condizioni o limitazioni di validità del certificato (se applicabile) Conditions for or limitations to the validity of the certificate (if applicable) // // Il coinvolgimento dell’organismo notificato ICIM spa è limitato agli aspetti previsti dall’articolo 52, paragrafo 7.a The involvement of the notified body ICIM spa is limited to the aspects required pursuant to Article 52 (7.a) Federico Pasqui Rappresentante Direzione / Management Representative ICIM S.p.A. PRIMA EMISSIONE FIRST ISSUE EMISSIONE CORRENTE CURRENT ISSUE DATA DI SCADENZA EXPIRING DATE ICIM S.p.A. – Piazza Don Enrico Mapelli, 75 – 20099 Sesto San Giovanni (MI) Società soggetta all’attività di direzione e c
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Certificato UE del Sistema di Gestione della Qualità EU Quality Management System Certificate ALLEGATO AL / ANNEX TO 0425-MDR-030138-00 Secondo l’Allegato IX Capo I e III del Regolamento UE 2017/745 According to Annex IX Chapter I and III of EU Regulation 2017/745 IDENTIFICAZIONE TIPOLOGIE E MODELLI IDENTIFICATION OF THE MODEL/TYPE Dispositivo – Gruppo di Dispositivi Device – Generic Device Group Classe / Class T-Fix/FixUp/eFix (fissatore monolaterale/single-sided fixator) Codici/Codes: 02-11XXX 11= fissatore mano-piede/ hand-foot fixator XXX= numero progressivo elemento mini-fissatore/ serial...
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ICIMCertificato UE del Sistema di Gestione della Qualita EU Quality Management System Certificate ALLEGATO AL / ANNEX TO 15/07/2025 15/07/2025 14/07/2030 Secondo I’Allegato IX Capo I e III del Regolamento UE 2017/745 According to Annex IX Chapter I and III of EU Regulation 2017/745 Federico Pasqui' Rappresentante Direzione /Management Representative PRIMA EMISSIONE EMISSIONE CORRENTE DATA DI SCADENZA FIRST ISSUE CURRENT ISSUE EXPIRING DATE ICIM S.p.A. - Piazza Don Enrico Mapelli, 75 - 20099 Sesto San Giovanni (MI) Societa soggetta all’attivita di direzion e e coordinamento di ICIM GROUP Srl
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Certificato UE del Sistema di Gestione della Qualità EU Quality Management System Certificate ALLEGATO AL / ANNEX TO 0425-MDR-030138-00 Secondo l’Allegato IX Capo I e III del Regolamento UE 2017/745 According to Annex IX Chapter I and III of EU Regulation 2017/745 Dispositivo – Gruppo di Dispositivi Device – Generic Device Group XXXXX= misura dell'attuatore/ actuator size Diametro/Diameter= 20≤D≤300 mm Classe / Class Tutti i codici attivati sono depositati presso ICIM spa e nessun nuovo valore può essere attribuito senza autorizzazione dell’ON / All actually in-use devices codes are filed with...
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ICIMCertificato UE del Sistema di Gestione della Qualita EU Quality Management System Certificate ALLEGATO AL / ANNEX TO 0425-MDR-030138-00Secondo I’Allegato IX Capo I e III del Regolamento UE 2017/745 According to Annex IX Chapter I and III of EU Regulation 2017/745 II t’O IAI099CH PRIMA EMISSIONE FIRST ISSUE Rappresentante Direzione /Management RepresentativeICIM S.p.A. EMISSIONE CORRENTE CURRENT ISSUE DATA DI SCADENZA EXPIRING DATE 15/07/2025 15/07/2025 14/07/2030 Dispositivo - Gruppo di Dispositivi Device - Generic Device Group ICIM S.p.A. - Piazza Don Enrico Mapelli, 75 - 20099 Sesto San...
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