Home›Finland›Bioretec, Ltd.

Bioretec, Ltd.

Finland · Tampere

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Israel, 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 3Class II 4Class III 0

plus 7 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

3active device licences

Class III 3

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States7 registration records, 9 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: Bioretec Ltd. · BIORETEC LTD · Bioretec Ltd

FDA 510(k) clearances by year

22006 · K062980

22007 · K072848

22008 · K080879

12013 · K130716

12014 · K133950

12023 · DEN220030

FDA listed device types

Pin, Fixation, Smooth 1Absorbable Metallic Bone Fixation Fastener 1Fastener, Fixation, Biodegradable, Soft Tissue 1Screw, Fixation, Bone 1Gauge, Depth 1Orthopedic Manual Surgical Instrument 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN220030	RemeOs Screw LAG Solid	2023-03-29
US	K133950	ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)	2014-01-22
US	K130716	BIORETEC ACTIVASCREW INTERFERENCE	2013-08-28
BR	80492009003	KIT DE INSTRUMENTAIS PARA PARAFUSOS ACTIVA SCREW	Class I
BR	80492009004	KIT DE INSTRUMENTAIS PARA ACTIVA PIN	Class I
BR	80492009002	KIT DE INSTRUMENTAIS PARA PARAFUSOS ACTIVA SCREW CANULADOS PEQUENOS E	Class I
CA	94128	ACTIVASCREW INTERFERENCE	Class III
CA	94132	ACTIVASCREW	Class III
CA	97985	ACTIVAPIN	Class III

Bioretec, Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies