generated: '2026-08-02'
method: searched
source: https://www.activsurgical.com/compliance
docs: https://www.activsurgical.com/compliance
summary: >-
  Activ Surgical is a regulated medical-device manufacturer, not an API provider. Its
  published conformance surface is entirely regulatory and quality-system based: EU MDR
  declarations of conformity, an ISO 13485:2016 quality management system, CE Mark
  approval and an FDA 510(k) clearance for the ActivSight Intelligent Light. No public
  API, machine-readable API contract, or API-facing standards conformance (OAuth 2.0,
  OpenID Connect, RFC 9457, FHIR, SCIM, OData) was found on any probed host as of this
  pass, so the API-side standards below are recorded as not applicable rather than failing.
standards:
- id: iso-13485-2016
  name: ISO 13485:2016 Medical devices - Quality management systems
  conforms: true
  evidence: ISO 13485:2016 certification listed on the published compliance page
  source: https://www.activsurgical.com/compliance
- id: eu-mdr-2017-745
  name: EU Medical Device Regulation (EU) 2017/745
  conforms: true
  evidence: >-
    Declarations of conformity published for the Light Engine and Imaging Modules, the
    Light Cable and Adapters, and the Reprocessing Trays
  source: https://www.activsurgical.com/compliance
- id: ce-mark
  name: CE Mark
  conforms: true
  evidence: CE Mark approval for ActivSight Intelligent Light announced December 2022
  source: https://www.activsurgical.com/news/activ-surgical-secures-ce-mark-approval-for-activsight-intelligent-light
- id: fda-510k
  name: US FDA 510(k) premarket notification
  conforms: true
  evidence: >-
    FDA 510(k) clearance of the ActivSight Intraoperative Imaging Module announced
    9 April 2021
  source: https://www.activsurgical.com/news/fda-clearance
- id: oauth2
  name: OAuth 2.0
  conforms: false
  applicable: false
  evidence: no public API or securityScheme published; no OAuth metadata at any probed host
- id: openid-connect
  name: OpenID Connect
  conforms: false
  applicable: false
  evidence: /.well-known/openid-configuration returned 404 on www.activsurgical.com
- id: rfc9457-problem-details
  name: RFC 9457 Problem Details for HTTP APIs
  conforms: false
  applicable: false
  evidence: no OpenAPI or error contract published
- id: rfc9116-security-txt
  name: RFC 9116 security.txt
  conforms: false
  evidence: /.well-known/security.txt returned 404 on www.activsurgical.com
- id: fhir-r4
  name: HL7 FHIR R4
  conforms: false
  applicable: false
  evidence: no clinical data-exchange interface published
- id: hipaa
  name: HIPAA
  conforms: false
  applicable: null
  evidence: no HIPAA statement found on the public compliance or privacy pages
x-evidence:
  fetched: '2026-08-02'
  probes:
  - {url: 'https://www.activsurgical.com/compliance', http_status: 200}
  - {url: 'https://www.activsurgical.com/.well-known/security.txt', http_status: 404}
  - {url: 'https://www.activsurgical.com/.well-known/openid-configuration', http_status: 404}