HomeIndiaBONETECH MEDISYS PVT LTD

BONETECH MEDISYS PVT LTD

India · Ahmedabad · www.bonetechmedisys.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN IN-MF-000020462

This company has registrations in European Union, Brazil — 2 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 IIb 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class I 2
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 Union408 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: BONETECH MEDISYS PVT. LTD

Regulatory identity

EU manufacturer SRN
IN-MF-000020462
EU authorised representative
Amstermed B.V.

Company information

Country
India
City
Ahmedabad
Website
www.bonetechmedisys.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationImplants & prosthetics

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.

Registration details (sample)

MarketIdentifierNameClass / date
EUG562BS10445250NEXPINEClass IIb
EUG562BS10365500NEXPINEClass IIb
EUG562BS10445300NEXPINEClass IIb
EUG562BS10365450NEXPINEClass IIb
BR80794390084INSTRUMENTAL PARA HASTE BLOQUEADA - BONETECHClass I
BR80794390085INSTRUMENTAL PARA CIRURGIA ORTOPEDICA - BONETECHClass I

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