WHO-GMP, CE,ISO,MDR
We are Government of India - MDR 2017 Approved facility With WHO-GMP, CE, ISO 13485:2016 & ISO 9001:2015 Complaince certificates.
Manufacturing with High Standard!
Dispowell Surgicals has a manufacturing facility with High Grade International Level Standards.
WHO-GMP Compliance No: QCAS-2022-DS-300711
Has been successfully implemented the Quality management System and found working satisfactorily as per the norms of “Good Manufacturing Practice” as laid down by “World Health Organization” which has been in conformance to the requirements of WHO-GMPFor the following scope: Manufacturer of Medical Devices and Disposable Surgical Products:- IV Infusion Sets Vented and Non Vented, IV Cannula, Scalp Vein Set, Blood Transfusion Set, Needle, Syringe, Catheter, Ryle Tube, Infant Feeding Tube, Measure Volume Burette Set, Urine Bag, Oxygen Mask, Nebulizer, Guedel Airways, Micro Drip, Ventilator Circuit, Surgical Gloves, Umbellical Cord Clamp and Other Class A & B Surgical abd Nedical devices.
CE Compliance Certificate No. – CE- 6098
We hereby declare that the technical file of product complied with the requirement of Directive MDD 93/42/EEC amended by 2007/47/EC, Medical Devices and Disposable Surgical Prodcuts:- IV Infusion Sets Vented and Non Vented, IV Cannula, Scalp Vein Set, Blood Transfusion Set, Needle, Syringe, Catheter, Ryles Tube, Infant Feeding Tube, Measure Volume Burette Set, Urine Bag, Oxygen Mask, Nebulizer, Guedel Airways, Micro Drip, Ventilator Circuit, Surgical Gloves, Umbellical Cord Clamp and other surgical items.
ISO 9001:2015: SCK/01/DIS/22/91/2173
Dispowell Surgicals is in accordance with the requirements of the following standard Issued by SCK Certifications Pvt. Ltd. Director ISO 9001:2015 (Quality Management System) for Manufacturer of Medical Devices and Disposable Surgical Products: - IV Infusion Sets Vented and Non-Vented, IV Cannula, Scalp Vein Set, Blood Transfusion Set, Needle,Syringe, Catheter, Ryles Tube, Infant Feeding Tube, Measure Volume Burette Set, Urine Bag, Oxygen Mask, Nebulizer, Guedel Airways, Micro Drip, Ventilator Circuit, Surgical, Gloves, Umbellical Cord Clamp and Other medical devices.
ISO 13485:2016 : IMC-2022-DS-3007012
Dispowell Surgicals has been independently assessed by IMC and is compliant with the requirement of the standard ISO 13485:2016 Quality Management System For Medical Devices For the following scope of activities Manufacturer of Medical Devices and Disposable Surgical Products: - IV Infusion Sets Vented and Non-Vented, IV Cannula, Scalp Vein Set, Blood Transfusion Set, Needle, Syringe, Catheter, Ryles Tube, Infant Feeding Tube, Measure Volume Burette Set, Urine Bag, Oxygen Mask, Nebulizer, Guedel Airways, Micro Drip, Ventilator Circuit, Surgical, Gloves, Umbellical Cord Clamp and other medical surgical products.
MDR Licence Number: MFG/MD/2022/000333
Dispowell-Surgicals has been licenced to manufacture for sale or for distribution the below listed medical device(s) at the premises situated at M/s DISPOWELL SURGICALS, Shed No-28, Yamuna Industrial Park, AT VillageDhamatvan,Vanch-Dhamatvan Road,, Dhamatvan,, Ahmedabad, Gujarat (India) - 382435. This Licence include Class B Approved more than 35 Products.
IMPORT EXPORT CODE: AASFD6399P
This is to certify that DISPOWELL SURGICALS is issued an Importer-Exporter Code (IEC) AASFD6399P. Dispowell Surgicals is approved exporter of Class 2 medical devices by DGFT (Government of India).
Neutral Code No: GJ/DEVICE/MFG/MD/2022/000333
Netral Code are issued by CDSCO to Dispowell Surgicals for Bulk export of Finished Mediccal device and Surgical disposable items.
INDIAN GST NO: 24AASFD6399P1ZC
We are Indian Goods and services tax registred firm located in Gujarat having own manufacturing facility for surgical disposable items.
Free sale Certificate: NCC/MD/2023/000166
We provide Free sale certificate of 40 products to the exporters and Importers for those countries which has this certificate mandantory.
Improving The Quality of Surgical Products.
Discover Our products in more than 50 Countries Worldwide!
Today, our company is one of the most valuable Surgical products suppliers in the India and Worldwide. Our Manufacturing usint is located in Ahmedabad, Gujarat, India with above listed quality certifications to provide international standard medical products at a best rates.
Dispowell Surgicals