Jaykay Enterprises unit gets medical device manufacturing licence

Guidance
medical devices

Blacklitt Research22 October 20262 min read

Jaykay Enterprises (NSE: JAYKAY) said its wholly owned subsidiary JK Digital & Advance Systems Private Limited has received a Licence to Manufacture Class C or Class D Medical Devices covering eight categories of advanced orthopaedic and spinal implants, it said in a filing on 22 Oct 2026. The licence is dated 21 Oct 2026 and is issued by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017.

Key highlights

Licence number: MFG/MD/2026/000784, dated 21 Oct 2026
Eight categories of implants covered
Validity: lifetime, per Annexure-A
Products made from titanium alloy powder (Ti6Al4V), sold under Neobone and Nubone

The licence in numbers

Item	Detail
Subsidiary	JK Digital & Advance Systems Private Limited, wholly owned by Jaykay Enterprises Limited
Licensing authority	Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare
Licence number	MFG/MD/2026/000784, dated 21 Oct 2026
Device class	Class C or Class D medical devices
Categories covered	Eight categories of advanced medical implants
Premises	First and Second Floor, Plot 477B, 4th Phase Peenya Industrial Area, 12th Cross, Bengaluru, Karnataka
Validity	Lifetime, per Annexure-A
Brand names	Neobone and Nubone

What the licence authorises

The licence allows JK Digital & Advance Systems Private Limited to manufacture for sale or distribution Class C or Class D medical devices at its Bengaluru premises. The filing lists eight categories: Lattice Acetabular Cups, Lattice Cone Acetabular Cups, Lattice Buttress Implants, Lattice Shim Implants, Lattice Cage Constructs, Lattice TLIF Spinal Implants, Lattice PLIF Spinal Implants, and Lattice Shells and Wedges.

The annexure lists 72 TLIF spinal implant sizes and 44 PLIF spinal implant sizes. The hip implants are described as used in complex hip revision surgeries and reconstruction of severe acetabular bone defects, and the spinal implants in lumbar interbody fusion procedures.

Conditions attached to the licence

The licence is subject to conditions set by the Central Licensing Authority. These include producing the licence on request, reporting any suspected serious adverse event within fifteen days, obtaining prior approval for major changes to manufacturing, informing the authority of minor changes within thirty days, testing each batch before release, and withdrawing or recalling product if directed.

The company says the licence establishes regulatory authorisation to manufacture these products, subject to those terms and applicable regulatory requirements. It says the development strengthens its presence in the specialised medical devices segment.

What the licence means for Jaykay Enterprises' shareholders

The licence gives JK Digital & Advance Systems Private Limited the regulatory authority to make the listed implant products at its Bengaluru premises. The filing does not say what revenue or profit the products will bring, when manufacturing will start, what the facility or investment costs, or whether any of the products have been sold in any market. The filing also does not state the reason for the timing of the application.

The filing gives no further dated step. The licence is stated as lifetime, and the company says it will host the disclosure on its website.

Reference: Original filing (PDF)

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