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Bioretec Ltd.

Matched from indexed company URL: Bioretec, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055368923005536892Bioretec Ltd.1N2026-01-01Yrittajankulma 5 Tampere Pirkanmaa FI FI-33710

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
06438394002678Activa Instrument - K-wire Ø1.6 mm, length 130 mm, for 1.5 mm pins/nails, 10 pcs.+358207789500sales@bioretec.com
06438394002685Activa Instrument - K-wire Ø2.0 mm, length 130 mm, for 2.0 mm pins/nails, 10 pcs.+358207789500sales@bioretec.com
06438394002692Activa Instrument - K-wire Ø2.8 mm, lenght 130 mm, for 2.7 mm pins/nails, 10 pcs.+358207789500sales@bioretec.com
06438394002708Activa Instrument - K-Wire Ø3.2 mm, length 130 mm, for 3.2 mm pins/nails, 10 pcs.+358207789500sales@bioretec.com
06438394004900ActivaScrew™ - ActivaScrew™ Cannulated LAG 4.0x70 mm, thread 32 mm+358207789500sales@bioretec.com
06438394009134ActivaScrew™ Interference - ActivaScrew™ Interference 9 x 20 mm+358207789500sales@bioretec.com
06438394010956Activa Instrument - K-wire Ø1.5 mm, length 130 mm, for 1.5 mm pins/nails, 10 pcs.+358207789500sales@bioretec.com
06438394020382Activa Instrument - K-Wire Ø3.2 mm, length 130 mm, for 3.2 mm pins/nails, 10 pcs.+358207789500sales@bioretec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
758101211985777K133950ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)HTY2014-01-22
758101634853592K130716BIORETEC ACTIVASCREW INTERFERENCEMAI2013-08-28
758101612993823K081392BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPINHWC2008-06-18
758101919646345K080879ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTMHTY2008-06-24
758101930406637DEN220030RemeOs™ Screw LAG SolidQJD2023-03-29
758101337466732
758101628225446
758101882551412

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HTY22014-01-22
QJD12023-03-29
MAI12013-08-28
HWC12008-06-18

PMN#

GUDID#

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