HomeIndiaMRK Healthcare Pvt. Ltd.

MRK Healthcare Pvt. Ltd.

India · Mumbai · www.mrkhealthcare.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN IN-MF-000019843

This company has registrations in European Union, United States, United Kingdom, Taiwan, South Korea, Israel, Russia — 7 overseas markets. 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
131UDI-DI device records
Class I 9Class IIa 122
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 Union131 raw hits, 0 excluded, 131 confirmed
United States2 registration records, 1 510(k), 0 PMA
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: MRK HEALTHCARE PVT.LTD

Regulatory identity

EU manufacturer SRN
IN-MF-000019843
EU authorised representative
Obelis s.a.
UK responsible person
Amstermed UK Ltd
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
India
City
Mumbai
Employees
500–1000
Company type
Manufacturer
Website
www.mrkhealthcare.com
Product categories
Integrated 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.

Business registration

Legal name
MRK HEALTHCARE PRIVATE LIMITED
LEI
335800SDW7VE6QANFI25
Registration status
Active
Legal form
Private Limited Company (Pvt Ltd)
Incorporated
2012-08-07
Registered address
S. NO. 153/P, PANCH PIPPAL, PATAN, 384265
Registration authority
Companies Register, no. U33110GJ2012PTC071480
Registry record updated
2026-01-13

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

12021 · K210969

FDA listed device types

Device, Incontinence, Urosheath Type, Non-Sterile 1Surgeon'S Gloves 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08905159007790NulifeClass IIa
EU08905159007783NulifeClass IIa
EU08905159007776NulifeClass IIa
EU08905159005628NulifeClass IIa
UK47178GLOMED PRO Double Pair Latex Surgical gloves Powder Free SterileClass IIa
UK47179GLOMED PRO Elbow Length Gynaecology Latex Surgical gloves Powdered SterileClass IIa
USK210969Nulife2021-11-03

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