EVIDENCE & CONTEXT Updated: 18 September 2026
Medical device regulationOriginal reviewedApplication + issued licence

CDSCO classification · Application and licence trail

Original application reviewed · Class B is recorded in the issued MD-5

What this means for your family

Reading the application and issued licence together helps you distinguish a requested classification from the device’s licensed classification.

Source review conclusion

The January application records a proposed Class A classification. The issued MD-5 identifies PinnacleAI® GPT-OS v1.0.0 as Class B. These documents are presented in their regulatory sequence.

Reported file
MD/classification/2025/150
Reported decision date
13 April 2026
Decision source
Reported in the dossier and September handout
Application source
8 January 2026 · proposed Class A

What this supports

The issued MD-5 identifies the device as Class B. Company publications describe a preceding Central Licensing Authority classification decision.

Scope & limits

The locally available risk-classification form is an application proposing Class A, not the approved Class B decision. A classification decision is also distinct from a manufacturing licence.

The separate 13 April 2026 CAL/decision is described in company publications; its issued copy was not available for inspection. This review does not authenticate that separate decision.

Source: Risk-classification application, p1; Evidence Dossier v2, pp23–24; September handout, physical pp1 and 9; operative MD-5, p1.
Reviewed: · Scope rechecked: 18 September 2026 · Application and issued MD-5 inspected; separate issued CAL not inspected.

This page summarizes the listed evidence; it is not an issuer’s verification service. A source review is separate from checking current issuer status.

Pinnacle Blooms Network is a brand of Bharath Healthcare Laboratories Private Limited. View legal identity evidence.

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