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Home›France›Cousin Biotech Sas

Cousin Biotech Sas

France · Wervicq-Sud Nord
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
pendingnot queried
USUnited StatesFDA openFDA
11listed device types
Class I 1Class II 10Class III 0
plus 12 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
4 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class III 6
15 including historic records
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.

United States12 registration records, 8 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: Cousin Biotech · COUSIN BIOTECH S.A.S. · COUSIN BIOTECH
Same-named companies — This database also contains companies with near-identical names: Cousin Biotech S.A.R.L. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France
City
Wervicq-Sud Nord

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

12000
12007
12008
12010
12014
22018
12019

FDA listed device types

showing 8 of 11
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis 1Thoracolumbosacral Pedicle Screw System 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Cerclage, Fixation 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Bone Fixation Cerclage, Sublaminar 1Mesh, Surgical, Polymeric 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181086Cortical Fixation Systems2019-01-09
USK181799ResCUBE™ Ligament Fixation System2018-08-29
USK172206NAJA™ Ligament Correction System2018-04-10
BR80003890048ANCILARES LIFTClass I
BR10210550114KITACINTRA INTRASPINEClass II
CA74482ANNEAU GASTRIQUE AJUSTABLE BIORING - KIT ANNEAU GASTRIQUE + CHAMBREClass III
CA74483ANNEAU GASTRIQUE AJUSTABLE BIORING - KIT DE REMPLACEMENTClass III
CA74777IMPLANT DE RENFORCEMENT SEMI-RESORBABLE 4DDOME - SANS PLAQUEClass III

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