Our quality management system is certified to ISO 13485:2016 and ISO 9001:2015. View or download each certificate below, or verify it with the issuing body.
Quality management system for medical devices
Current. Next surveillance audit due 18 August 2027| Certificate number | 260819M101 |
|---|---|
| Issued by | Arcade Management Certification (AMC), Manchester, UK |
| Date of registration | 19 August 2026 |
| Surveillance audits due | 18 August 2027 and 18 August 2028 |
| Recertification due | 18 August 2029 |
| Sites named | Registered office in Lucknow and factory at Palta, Dewa Road, Barabanki, Uttar Pradesh |
Quality management system
Current. Next surveillance audit due 18 August 2027| Certificate number | 260819Q103 |
|---|---|
| Issued by | Arcade Management Certification (AMC), Manchester, UK |
| Date of registration | 19 August 2026 |
| Surveillance audits due | 18 August 2027 and 18 August 2028 |
| Recertification due | 18 August 2029 |
| Sites named | Registered office in Lucknow and factory at Palta, Dewa Road, Barabanki, Uttar Pradesh |
Technical file assessed against EU MDR 2017/745
Current. Next surveillance audit due 18 August 2027| Certificate number | CE-1438 |
|---|---|
| Issued by | Arcade Management Certification (AMC), Manchester, UK |
| Date of registration | 19 August 2026 |
| Surveillance audits due | 18 August 2027 and 18 August 2028 |
| Recertification due | 18 August 2029 |
| Sites named | Registered office in Lucknow and factory at Palta, Dewa Road, Barabanki, Uttar Pradesh |
Form MD-5, Medical Devices Rules, 2017 (India)
| Licence number | MFG/MD/2026/000291 |
|---|---|
| Issued by | State Licensing Authority, Uttar Pradesh |
| Covers | Manufacture of our Class A and Class B devices at the Barabanki plant |
| Copy | Shared with buyers on request, with the product annexure |
The ISO 13485:2016 and ISO 9001:2015 certificates and the certificate of compliance cover the manufacture of:
disposable hypodermic syringes (with and without needle), auto-disable sterile hypodermic syringes with needle, disposable hypodermic needles, IV cannulas, infusion sets, blood transfusion sets, scalp vein sets, 3-way stop cocks, Ryles tubes, Yankauer suction sets, extension tubes, blood collection needles, umbilical cord clamps, infant feeding tubes, spinal needles and Foley catheters.
Tender and registration files often need more than a certificate. Ask us for the licence annexure, product specification sheets, sterilisation records or batch documents for the products you are buying.
Request documents