MD-5 · Class B manufacturing licence
PinnacleAI® GPT-OS v1.0.0 · Non-diagnostic developmental-support software
What this means for your family
A defined intended use lets your family understand what the software is designed to support and when professional clinical evaluation is needed.
- Licence number
- MFG/MD/2026/000248
- Issuer
- State Licensing Authority · Telangana Drugs Control Administration
- Licence holder
- Bharath Healthcare Laboratories Pvt. Ltd.
- Issued
- 21 April 2026
- Intended population
- Children aged 0–12
- Intended functions
- Developmental ability measurement, readiness tracking, progress forecasting and adaptive therapy-plan support
What this supports
The supplied Form MD-5 licenses the listed Class B device for manufacture for sale or distribution at the specified premises. Intended users include parents, therapists, educators and caregivers supporting children aged 0–12.
Scope & limits
Applies to the named device, version, intended use and premises. It does not establish diagnostic authority, clinical effectiveness or the registration of every centre.
The operative licence reads 000248. A corrected forwarding letter also reads 000248; the older forwarding letter supplied as PinnacleAI®_SAMD_License_CL.pdf also reads 000150. The CL file is a forwarding letter, not a separate classification approval. Use the operative licence and corrected letter together.
Source: Original Form MD-5, page 1 including device annexure; supplied PinnacleAI®_SAMD_License.pdf re-inspected 18 September 2026.
Reviewed: · Scope rechecked: 18 September 2026 · Current issuer or registry status: not independently confirmed.
This page summarizes the listed evidence; it is not an issuer’s verification service. A source review is separate from checking current issuer status.