Equinox Biotech Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30052166563005216656Equinox Biotech Co., Ltd.1N2026-01-01Rongsheng Technological Zone UNIVERSITY ROAD, Shantou Guangdong CN 515063

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850014758363NATALIST - NATALIST EARLY Pregnancy Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. There are 4pcs of midstream in each box.1-843-5807572liz@natalist.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
241761720427024K991067MODIFICATION OF: DAVIDSTRIP HCGJHI1999-04-27
241761708654541K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test CassetteLCX2019-02-22
241761129059335K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteLCX2018-03-28
241761133121996K053236DAVID PREGNANCY TEST (MIDSTREAM)LCX2006-07-18
241761377097296
241761474531027
241761867066770
241761971611848

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCX32019-02-22
JHI11999-04-27

GUDID#

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