Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN 3H

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

CoaChrom Diagnostica GmbH

Authorized representative

🇦🇹 Austria

DORAN INTERNATIONAL

Authorized representative

🇫🇷 France

Safeguard Technologies Limited

Authorized representative

🇮🇪 Ireland·3 Manufacturers·2 Devices

X-FRAME DRF

Basic UDI-DI

EU MDR · Eu Md Class 2b ·ITALRAY s.r.l.·1 device

Dalt del Sol, S.L.

Importer

🇪🇸 Spain

Epic Den Bosch B.V.

Importer

🇳🇱 Netherlands·1 Manufacturer

Apothicom Distribution

Importer

🇫🇷 France·1 Manufacturer

DEA SRL

System producer

🇮🇹 Italy

DEX SURGICAL

System producer

🇫🇷 France

DIAMOND BUR 4103EC - Box with 10

Device

EU MDR · Eu Md Class 1 ·3R Indústria E Comércio LTDA·On the market

DIAMOND BUR 4103C - Box with 10

Device

EU MDR · Eu Md Class 1 ·3R Indústria E Comércio LTDA·On the market

DIAMOND BUR 4102C - Box with 10

Device

EU MDR · Eu Md Class 1 ·3R Indústria E Comércio LTDA·On the market

DIAMOND BUR 4084C - Box with 10

Device

EU MDR · Eu Md Class 1 ·3R Indústria E Comércio LTDA·On the market

DIAMOND BUR 4072HL - Box with 10

Device

EU MDR · Eu Md Class 1 ·3R Indústria E Comércio LTDA·On the market

DIAMOND BUR 4072F - Box with 10

Device

EU MDR · Eu Md Class 1 ·3R Indústria E Comércio LTDA·On the market

DIAMOND BUR 3833EC - Box with 10

Device

EU MDR · Eu Md Class 1 ·3R Indústria E Comércio LTDA·On the market