HomeChinaREACH SURGICAL, INC.

REACH SURGICAL, INC.

China · Tianjin
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Hong Kong, 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
23 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
7active ARTG entries
IIa 1IIb 6
HKHong KongMDACS
4valid listings
Class III 4
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
12active registrations
Class 2a 2Class 2b 10
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.

United States1 registration records, 3 510(k), 0 PMA, 7 excluded
Brazil2 confirmed, 3 excluded
Saudi Arabia0 confirmed, 2 excluded
Manufacturer names merged into this page: REACH SURGICAL, INC. · REACH SURGICAL, INC · Reach Surgical, Inc.

Company information

Country
China
City
Tianjin

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

12008 · K071023
12012 · K120179
12019 · K192566

FDA listed device types

Staple, Implantable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK192566Reach and CQ'ENCE Circular Staplers2019-10-17
USK120179REACH SURGICAL STAPLERS2012-05-23
USK071023REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C2008-08-28
BR81504790200GRAMPEADOR DE CORTE LINEAR ENDOSCÓPICO ENDO REACH - ENDO IIIClass II
BR81504790204GRAMPEADOR ENDOSCÓPICO LINEAR CORTANTE ENDO REACHClass II

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