R-001-003 List of external documents

• Governed by GP-001 Control of documents
• Comes from template T-001-003 List of external documents

Certificates and Accreditations

Name	Source	Reference / ID	Issue Date	Expiry Date	Location
ISO 13485 Certificate	BSI	MD 765616	2023-08-01	2026-08-01	/licenses-and-accreditations/BSI/iso-13485-certificate-folder
Notified Body Confirmation Letter	BSI	NB 2797	2024-01-15	-	/licenses-and-accreditations/BSI/notified-body-confirmation-letter-folder

Regulatory Registrations - European Union

Name	Source	Reference / ID	Registration Date	Location
EUDAMED Actor Identification	EUDAMED	ES-MF-000025345	2023-06-01	/licenses-and-accreditations/EUDAMED/actor-identification
EMA OMS Registration	EMA	ORG-100048249 / LOC-100079838	2023-05-01	/licenses-and-accreditations/ema-oms

Regulatory Registrations - Spain (AEMPS)

Name	Source	Reference / ID	Issue Date	Location
Manufacturer License	AEMPS	-	2023-01-01	/licenses-and-accreditations/AEMPS/Authorization/manufacturer-license
Product Registration	AEMPS	-	2023-01-01	/licenses-and-accreditations/AEMPS/Authorization/product-registration

Regulatory Registrations - United Kingdom

Name	Source	Reference / ID	Issue Date	Location
MHRA Registration	MHRA	-	2023-03-12	/licenses-and-accreditations/MHRA/mhra-registration

Regulatory Registrations - United States

Name	Source	Reference / ID	Issue Date	Expiry Date	Location
FDA Small Business Certificate	FDA	-	2024-01-01	2024-12-31	/licenses-and-accreditations/FDA/fda-small-business

Regulatory Registrations - Brazil

Name	Source	Reference / ID	Issue Date	Location
RDC 751/2022 Approval	ANVISA	-	-	/licenses-and-accreditations/ANVISA

Nomenclature

Name	Source	Code	Description
GMDN Code	GMDN Agency	65975	Dermatoscopic image interpretive software

Insurance

Name	Source	Policy Year	Location
Civil Liability Insurance	Insurance provider	2025	/licenses-and-accreditations/civil-liability-insurance

Data Protection

Name	Source	Year	Location
Data Protection Compliance	Data Protection Authority	2023	/licenses-and-accreditations/data-protection

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager