FSC · Free Sale Certificate for export
Export-purpose certificate issued on the MD-5 licence · PinnacleAI® GPT-OS v1.0.0
Source review conclusion
Certificate FSC/MD/2026/000741 was inspected and its device particulars agree with the operative MD-5 scope. It establishes Indian domestic marketability and export eligibility subject to the importing country’s law. No foreign registration or comparative superiority is claimed.
- Certificate number
- FSC/MD/2026/000741
- Issuer
- State Licensing Authority · TG SAFE (Telangana Standards Authority for Food and Essential Drugs), Government of Telangana
- Licence holder
- Bharath Healthcare Laboratories Private Limited
- Issued
- 23 September 2026
- Base licence
- Form MD-5 · MFG/MD/2026/000248
- Permitted activity
- Manufacture and sale in the domestic market as per Indian law; export as per the law of the importing country
- Device as printed
- Developmental Support Software (Non-Diagnostic) · Software as a Medical Device · Class B · PinnacleAI GPT-OS v1.0.0 · children aged 0–12 · non-sterilized · shelf life NIL
- Intended functions
- Developmental ability measurement, readiness tracking, progress forecasting and adaptive therapy-plan support
What this supports
The supplied certificate records that Bharath Healthcare Laboratories Private Limited holds manufacturing licence MFG/MD/2026/000248 under Form MD-5 and is permitted to manufacture the listed device for sale in the domestic market under Indian law and for export as per the law of the importing country. The device particulars agree with the operative MD-5 scope: non-diagnostic developmental-support software, Class B, version 1.0.0, for parents, therapists, educators and caregivers supporting children aged 0–12.
Scope & limits
A Free Sale Certificate records the Indian regulatory standing and export eligibility of the named licensed device. It is not a registration, approval or marketing authorisation in another country; each importing regulator applies its own requirements. No validity period is printed on the certificate. It does not establish diagnostic authority, clinical effectiveness, comparative superiority or the registration of any centre.
Application reference FSC/MD/2026/204866, dated 15 September 2026, is distinct from certificate FSC/MD/2026/000741. The FSC cites base licence MFG/MD/2026/000248 as issued on 20 April 2026; the supplied Form MD-5 instrument is dated 21 April 2026. Both identifiers and dates are preserved as printed. The public copies remove the visible digital-signature image while retaining the signatory name and designation; the original signed files remain in the private source set.
Source: Free Sale Certificate FSC/MD/2026/000741 and forwarding letter F.No FSC/MD/2026/204866, both dated 23 September 2026; original signed files inspected 24 September 2026.
Source inspected: · Scope rechecked: 24 September 2026 · Original certificate and forwarding letter inspected. Their populated signature fields were observed, but cryptographic signature validity was not independently verified.
The exact source
Section linkthe said firm is permitted to manufacture the products for their manufacture and sale in domestic market as per indian law and for export as per law of importing country (s).
Privacy-safe public source copy. The visible digital-signature image is removed; signatory name and designation remain.
Source inspection: . Original Free Sale Certificate and forwarding letter inspected as text and page images; certificate number, licence number, product particulars, intended use and export condition compared with the supplied MD-5. The FSC supports Indian domestic marketability and export eligibility for the named licensed device. It is not foreign registration, comparative clinical evidence or a cryptographic validation of the embedded signature.
Record revision history
- — Added the inspected FSC, forwarding letter, privacy-safe public copies and explicit importing-country-law boundary.
Cite this evidence summary
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This page summarizes the listed evidence; it is not an issuer’s verification service. A source review is separate from checking current issuer status.