Polymed Medical Devices Market Overview and Financial Snapshot
R&D, REGULATORY AND PROCESS CAPABILITIES
POLYMED
MEDICAL
DEVICES
We Care As We Cure
FULLY INTEGRATED FROM NEW PRODUCT DESIGN DEVELOPMENT TO AUTOMATED MANUFACTURING
◉
250+ Patents & 300+ pending applications
R&D Team with 50+ engineers and 10+ Clinical Consultants
All products are CE certified (EU Regulatory Compliant)
HIGHLY QUALIFIED
TEAM
•
Regulatory team specialized
in EC, FDA regulations
Clinical Specialists Team
PRODUCT
DESIGN
.
Multi product design
capability thru SUT
Knowledge of global IP laws
MOLD DESIGN &
PROCESS
DEVELOPMENT
.
Shorter development time
• Using high end design
softwares
TOOL & MACHINE
MANUFACTURING
www.polymedicure.com
Leveraging latest
technologies
•
Reducing time to Market
ZERTIFIKAT CERTIFICATE сЕРТи икАT CERTIFICADO CERTIFICAT
R&D Center, India
TUV
ALSTONE
MAKINO
Protect Service
R&D
EC Certificate
Production Quality Assurance System
Directive 93/42/EEC on Medical Devices (MDD), Annex V
(Devices in Class la, llb or ill
No. G2 105735 0002 Rev. 00
Manufacturer:
Product
Category(ies):
Poly Medicure Limited
Plot No.PA 010-019 Light Engineering
Sector, Mahindra World City, Special Economic Zone
302037 Jaipur, Rajasthan
INDIA
IV Cannula (Catheter with/without Safety Features), Infusion
sets. Flow Regulators. Burette Infusion Set Stop cocks with/
without extension ine. Extension ine. Transfusion Set (BT Set)
Yankaur Suction Set (Suction tube and/or Handle). Thoracic
Drainage Catheter with without Trocar. Infant Feeding tube
Mucus Extractor with/without bacterial fiter. Suction catheter.
The Certification Body of TÜV SÜD Product Service GmbH declares that the aforementioned
manufacturer has implemented a quality assurance system for manufacture and final inspection of
the respective devices/device categories in accordance with MDD Annex V. This quality assurance
system conforms to the requirements of this Directive and is subject to periodical surveillance. For
marketing of class llb and ill devices an additional Annex I certificate is mandatory. See also notes
overleaf
Report No.
Valid from:
Valid until
Date,
IND2019092
2020-04-16
2004-05-26
2020-04-16
D
Christoph Dicks
Head of Certification/Notified Body
Page 1 of 2
TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123
TÜV SÜD Product Service GmbH-Certification Body Ridlerstraße 65-80338 Munich Germany
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