Home›India›Poly Medicure Limited (POLYMED)

Poly Medicure Limited (POLYMED)

India · New Delhi · www.polymedicure.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN IN-MF-000043010

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥100, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥100UDI-DI device records

Class I 5Class IIa 95

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

17listed device types

Class I 14Class II 3Class III 0

plus 18 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

117registered device records

Class I 30Class IIa 79Class IIb 5Class III 1IVD A 2

BRBrazilANVISA

108registered devices

Class I 42Class II 66

114 including historic records

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

26active ARTG entries

Class I 2IIa 16IIb 6Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

18active registrations

Class 1 4Class 2a 10Class 2b 3Class 3 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union5,111 raw hits, 0 excluded, 100 confirmed. Large result set — only the first 300 verified

United States18 registration records, 6 510(k), 0 PMA

United Kingdom117 confirmed, 0 excluded

Brazil108 confirmed, 3 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: POLY MEDICURE LTD. · POLY MEDICURE LTD · POLY MEDICURE LIMITED · POLY MEDICURE LTD. (FARIDABAD) · POLY MEDICURE LIMITED (NEW DELHI) · Poly Medicure Limited

Regulatory identity

EU manufacturer SRN: IN-MF-000043010
EU authorised representative: Obelis s.a.
UK responsible person: CMC Medical Devices LTD

Business registration

Legal name: POLY MEDICURE LIMITED
LEI: 335800XM9YRKFWFVXO61
Registration status: Active
Legal form: Public Limited Company (Ltd)
Incorporated: 1995-03-29
Registered address: PROPERTY NO. - 232B, THIRD FLOOR, OKHLA INDUSTRIAL ESTATE, PHASE-III NEW DELHI SOUTH DELHI, NEW DELHI, 110020
Registration authority: Companies Register, no. L40300DL1995PLC066923
Registry record updated: 2026-08-01

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

32023 · K231401

12024 · K232234

12025 · K252677

12026 · K252513

FDA listed device types

showing 8 of 17

Mask, Oxygen, Low Concentration, Venturi 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Brush, Scrub, Operating-Room 1Suction Catheter Kit 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Catheter, Irrigation 1Airway, Oropharyngeal, Anesthesiology 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08902095144121	Infusion Sets with flow regulator	Class IIa
EU	08902095132081	Disposable Extention set (Three way with extension tube)	Class IIa
EU	08902095132098	Disposable Extension set (Multiline-5)	Class IIa
EU	08902095132074	Disposable Extension set (Multiline NEO)	Class IIa
UK	64574	IV Cannula / Catheter with / without Safety Features)	Class IIa
UK	46967	Endotracheal Tubes with Cuff	Class IIa
UK	65416	Infusion Sets	Class IIa
US	K252513	Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)	2026-04-01
US	K252677	Polyshield Safety IV Catheters	2025-11-05
US	K232234	Nouvo Safety Set	2024-03-15
BR	10150470472	Cateter para infusão intravenosa de uso periférico sobre agulha Polyme	Class II
BR	10150470473	Cateter para infusão intravenosa de uso periférico sobre agulha com di	Class II
BR	10150479167	Sonda para nutrição enteral Polymed	Class II
SA	ME0000007880SFDAA00004	polyciser	—