HomeIndiaKANAM LATEX INDUSTRIES PRIVATE LIMITED

KANAM LATEX INDUSTRIES PRIVATE LIMITED

India · Kottayam Kerala · www.kanamlatex.com
✓ Record-verifiedregistrations found in 11 marketsEU SRN IN-MF-000022741

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥300, 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
≥300UDI-DI device records
Class I 6Class IIa 294
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 11 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
14registered device records
Class I 6Class IIa 8
BRBrazilANVISA
3registered devices
Class II 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 Union437 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States11 registration records, 6 510(k), 0 PMA
United Kingdom14 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: KANAM LATEX INDUSTRIES PVT. LTD. · KANAM LATEX INDUSTRIES PRIVAT LIMITED. · M/s.KANAM LATEX INDUSTRIES PRIVATE LIMITED

Regulatory identity

EU manufacturer SRN
IN-MF-000022741
EU authorised representative
Amstermed B.V.
UK responsible person
Amstermed UK Ltd

Company information

Country
India
City
Kottayam Kerala
Website
www.kanamlatex.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instrumentsIntegrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11990 · K897139
11991 · K904972
12002 · K013914
12004 · K033564
22005 · K052728

FDA listed device types

Surgeon'S Gloves 1Latex Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
EU00806363025571Surgicare PremierClass IIa
EU00806363025557Surgicare PremierClass IIa
EU00806363025533Surgicare PremierClass IIa
EU00806363501600SurgicareClass IIa
UK47172Clinex - Non-Sterile Latex Examination Gloves - Powder Free (Regular and Long Cuff)Class I
UK47172Kaltex 240mm Sterile Examination Gloves Latex – Powder Free (Regular)Class I
UK47173Clinex - Non-Sterile Latex Examination Glove - - Powdered (Regular and Long Cuff)Class I
USK052728POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES2005-12-05
USK052214PRE-POWDERED STERILE EXAM GLOVES2005-09-13
USK033564POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM22004-02-24
BR80256179004LUVA CIRÚRGICA LIFE NEOClass II
BR80256179005LUVA CIRÚRGICA LIFE ORTHOClass II
BR80256179006LUVA CIRÚRGICA LIFE GYNEClass II
SAME0000006502SFDAA00003Powder Free Non-Sterile Hand Specific Latex Examination Gloves

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