SERF

France · Decines-Charpieu

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 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

pendingnot queried

USUnited StatesFDA openFDA

12listed device types

Class I 5Class II 7Class III 0

plus 10 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

18 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

31active ARTG entries

Class I 10Class III 12IIa 6IIb 3

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

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 States10 registration records, 4 510(k), 0 PMA

Brazil7 confirmed, 1 excluded

Manufacturer names merged into this page: SERF

FDA 510(k) clearances by year

12011 · K111572

12015 · K142675

12018 · K181744

12023 · K223745

FDA listed device types

showing 8 of 12

Template 1Gauge, Depth 1Tray, Surgical, Instrument 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Orthopedic Manual Surgical Instrument 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223745	Novae® Dual Mobility System, Hype® Hip System	2023-12-22
US	K181744	BI-MENTUM dual mobility system	2018-12-11
US	K142675	CI../..X liner for NOVAE Dual Mobility Acetabular Cup	2015-01-15
BR	81038850008	Kit Instrumental novae cup	Class I
BR	80145901934	Bi-Mentum Instrumentais SERF	Class I
BR	81038850003	Kit Instrumental Hype Acetabular	Class I

SERF

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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