EN ISO 13485:2016
Certificate No. 24 0089 SJ
European market access platform of SPM Medicare Pvt. Ltd.
Manufacturer-backed medical devices for European healthcare.
We give European hospitals, GPOs, distributors and importers a direct line to SPM Medicare's manufacturing — an EN ISO 13485:2016 certified producer of hospital line-management and vascular access devices. One relationship, manufacturer-level pricing, and full documentation issued with every quotation.
EU MDR quality management system certificate issued by TÜV SÜD (Notified Body 0123). EN ISO 13485:2016 certified manufacturing. US FDA 510(k) cleared devices.
About SPM Eurocare
The manufacturer
SPM Medicare Pvt. Ltd.
Noida, India. Cleanroom production and in-house ETO sterilization
under a certified quality management system, exporting to markets across four continents.
The European platform
SPM Eurocare
Your commercial interface in Europe — quoting, documentation,
samples, regulatory confirmation and supply continuity, handled locally.
Who we work with
European healthcare
Hospitals and healthcare groups, GPOs and national procurement
bodies, distributors and importers, and OEM or private-label partners.
Why SPM Eurocare
Advantages of the market access model.
Four reasons European buyers work with us directly rather than through the usual chain of intermediaries.
Cost-saving figures are SPM Eurocare's own commercial estimate based on direct manufacturer-level pricing, not an independently audited result. Actual savings depend on the products, volumes and terms agreed.
What we supply
Hospital line management, end to end.
We supply the consumables that keep a vascular access line working — from establishing the line to conditioning, protecting and delivering through it.
EN ISO 13485:2016
Certified quality management system, valid to November 2027.
EU MDR QMS certificate
Regulation (EU) 2017/745, issued by TÜV SÜD, Notified Body 0123.
Cleanroom manufacturing
Controlled environment production with in-house ETO sterilization.
Multi-country registrations
Product registrations held across Europe, the Americas, the Gulf and Asia-Pacific.
Quality & compliance
Credentials you can verify.
Each certificate below names its issuing body and reference number, so your quality team can check it independently rather than take our word for it.
EU MDR QMS certificate
No. G10 120386 0002 Rev. 00
US FDA 510(k)
K231724
EU regulatory identifiers
- Manufacturer SRN
- IN-MF-000011829
- Notified Body
- TÜV SÜD Product Service GmbH (0123)
- EU Authorised Representative
- Med Devices Lifesciences B.V., Amsterdam
Status for your market
Regulatory status is held per device and per country, and the certificates above do not automatically extend to every item we can supply. Rather than publish a status that may not apply where you are, we confirm it in writing against what you are actually sourcing.
Product availability, regulatory status, indications and specifications may vary by country and by product. Please contact SPM Eurocare for product-specific information.
Get in touch
Tell us what you need.
The fastest route is to describe what you are sourcing. We will come back with availability, documentation and pricing — or route you to the right specialist.
Hospitals & healthcare groups
Evaluating a supply relationship, consolidating categories, or trialling on a ward.
GPOs & institutional buyers
Framework agreements, tenders and multi-site supply across a hospital network.
Distributors & importers
Territory, registration support and commercial terms.
Or contact us directly
info@spmmedicare.com ·
+91-8407070718
Send an enquiry
We only ask for what we need in order to reply usefully.
Common questions.
SPM Medicare Pvt. Ltd. is the manufacturer, producing under a certified quality management system with cleanroom facilities and in-house ETO sterilization. SPM Eurocare is its European market access platform — the commercial interface through which European buyers reach that manufacturing capability directly, at manufacturer-level pricing.
Send us your requirement and we will respond with the specifications, documentation and pricing for exactly those items. Configurations, sizes and presentations are set per contract, so a tailored response is more accurate than a generic list — and it usually reaches you faster. Samples are available for evaluation by healthcare institutions and distribution partners.
Both routes exist. We work with hospitals and healthcare groups, with GPOs and national procurement bodies, and with distributors and importers who hold the local market relationship. Which applies depends on your country and segment — tell us your situation and we will explain the route for your market.
Send us the item list and the country. Regulatory status and European stock position are held per device and per market, so we confirm both in writing against what you are actually sourcing rather than publishing a blanket claim here.