ISO 13485 and CE certified single-use clinical supplies manufactured under strict ISO Class 7 & 8 cleanroom environments for hospital networks and global distributors.
Engineered for safety, biostability, and precision flow dynamics. Designed to satisfy international healthcare tenders and hospital procurement standards.
High-grade vascular access devices engineered for critical renal care and hemodialysis procedures with minimal trauma and optimal flow rates.
Precision IV administration sets, safety cannulae, and blood transfusion lines designed to prevent contamination and maintain fluid precision.
Ergonomic urinary collection and drainage solutions featuring biocompatible silicone coating and smooth eyelets for patient comfort.
Comprehensive airway management consumables and respiratory delivery systems meeting stringent ICU and operating room requirements.
Post-operative closed wound suction systems, chest drainage units, and surgical wound closure devices engineered for clinical reliability.
Enteral feeding tubes, gastric decompression lines, and ostomy accessories crafted from non-toxic, medical-grade PVC and silicone.
Operating from our integrated manufacturing plant in Ahmedabad, India, we maintain complete oversight over materials, moulding, cleanroom assembly, and sterilisation validation.
Devices are processed in ISO Class 7 and Class 8 cleanrooms equipped with continuous HEPA air filtration, positive pressure monitoring, and strict particulate controls to ensure ultra-low bioburden.
Every product line is fully documented with ISO 10993 biocompatibility summaries, EO residue analysis, shelf-life stability studies, and Free Sale Certificates required for MOH product registrations globally.
We partner with medical distributors worldwide to offer buyer-branded packaging, custom pouch printing, multilingual IFUs, GS1 barcode formatting, and UDI compliant label artwork.
Convenient access to Mundra and Nhava Sheva ports allows seamless containerised exports. Standard lead time is 3 to 4 weeks, backed by dedicated export account managers.
Answers to common questions from hospital purchasing officers, tender contractors, and medical equipment importers.
Yes. All single-use medical disposable devices manufactured by Mediplus (Shree Umiya Surgical Pvt. Ltd.) are produced under a certified ISO 13485 Quality Management System. Product ranges hold CE certifications compliant with international medical device regulations, ensuring seamless acceptance in hospital tender processes worldwide.
Yes. We provide complete OEM contract manufacturing. This includes custom branding on sterile peel-pouches, multilingual IFU creation, outer carton customizations, barcoding, and Unique Device Identification (UDI) setup according to distributor specifications.
Our in-house regulatory department provides full technical documentation including ISO 13485 certificates, CE certificates, Free Sale Certificates (FSC), ISO 10993 biocompatibility testing, sterilisation validation reports, and real-time stability data to expedite Ministry of Health approval in your target country.
Standard catalogue orders ship within 3 to 4 weeks after order confirmation. Private-label OEM packaging or specific regulatory batches typically take 6 to 8 weeks depending on tooling and artwork approvals. Delivery terms include FOB, CIF, and CFR modes.
Seven clinical ranges, 400+ single-use device SKUs.
Catalogue, product sheets and certificate references.
Recognitions, approvals and export milestones.
Technical, regulatory and after-sales assistance.