Global Reach

Bring OPTIVEIN to your market

We partner with medical device distributors and laser OEMs worldwide — backed by ISO 13485 manufacturing, CDSCO licensing and the export documents your registration needs.

Beyond India

A manufacturing partner, not just a supplier

From our ISO 13485 & ICMED-certified facility in Thane, India, we manufacture OPTIVEIN bare tip surgical laser fibers in-house — which means distributor pricing, fast lead times, custom configurations and direct access to our engineering team.

We are actively building distributor partnerships across:

South Asia Southeast Asia Middle East Africa CIS Countries Latin America
Regulatory note: OPTIVEIN fibers are not yet CE-marked, so we currently do not offer them for sale in the EU / EEA. In markets that accept country-of-origin approvals, your local registration is supported by our Free Sale Certificate, ISO 13485 / ICMED certification and CDSCO manufacturing licence.
Glowing optical fiber ends — OptiVein surgical laser fibers
Registration Support

Documents that carry your registration

Most markets outside the EU register imported medical devices through a local distributor using manufacturer documentation. We hold the full set — shared under NDA / on request for your due-diligence and submission.

Quality

ISO 13485:2016 & ICMED 13485

International + Indian medical device QMS certification (TÜV India, NABCB-accredited). Public — download anytime.

View certificates
Export

Free Sale Certificate

Issued by CDSCO — confirms OPTIVEIN is freely sold in India. The key document for registration in most non-EU markets.

Held · on request
Licence

CDSCO Form MD-9

Indian national manufacturing licence for Class A/B medical devices, with OptiVein product endorsement.

Held · on request
Product files

Datasheets & supporting certificates

Technical datasheets (prepared per MDSAP), Market Standing and Non-conviction certificates for your dossier.

On request
How It Works

From first enquiry to repeat supply

01

Enquiry & evaluation

Tell us your market, specialities and expected volumes. We share catalogues, datasheets, certificates and commercial terms — samples for evaluation on request.

02

Registration in your market

Your team registers OPTIVEIN with the local authority; we support you with the Free Sale Certificate, quality certificates and any manufacturer declarations required.

03

Supply & scale

In-house manufacturing means dependable lead times and consistent quality order after order — with custom core sizes, connectors and OEM configurations as you grow.

For Laser Manufacturers

OEM supply, built to your specification

Bundle OPTIVEIN fibers with your diode laser systems — core size, connector, length and labelling configured to your requirements, at manufacturer-direct pricing.

200–600µm core sizes
SMA / FCconnector options
440–2200nm wavelength range
300 Wmax diode power
Start the Conversation

Become a distributor or OEM partner

Tell us about your company and market — we'll come back within one business day with the dossier and commercial terms.

Prefer email or WhatsApp? Write to arkayaoptics@gmail.com or message +91 77188 29759.