EUDAMED update: Nov 18, 2025

Siemens Healthcare Diagnostics Inc.

US-MF-000016336

Active284 devices

Address: GBC Drive, 500 DE 19714 Newark
Role: Manufacturer
Date of registration: Nov 10, 2021
Country: United States

Siemens Healthcare Diagnostics Inc. is a medical device manufacturer registered in EUDAMED. The company has 284 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in Newark, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Siemens Healthcare Diagnostics Inc.

: US-MF-000016336
Role: Manufacturer
Country: United States
Organization name: Siemens Healthcare Diagnostics Inc.
EU VAT number: Not applicable
EORI: no EORI
Trade register: no National trade register
Date of registration: Nov 10, 2021

Contact details for Siemens Healthcare Diagnostics Inc.

Phone: +1 877 229 3711
Email: contact@siemens-healthineers.com
Website: www.siemens-healthineers.com
Address: 500, GBC DRIVE DE 19714 NEWARK UNITED STATES

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Competent authority

Name: Health Products Regulatory Authority, Medical Devices Department

Phone: +353 1 676 4971
Email: devices@hpra.ie

Officers and regulatory representatives of Siemens Healthcare Diagnostics Inc.

BAEZ Henry
Dimension/Vista Reagents Syva Reagents Dimension EXL systems
Hidden
PIPES Andrea
Dimension/Vista Reagents Syva Reagents Dimension EXL systems
Hidden
AKINRINOLA Felix
Stratus® Reagents/Instruments/Calibrators
Hidden
HANSEN Erin
Stratus® Reagents/Instruments/Calibrators
Hidden

Connected operators

Importers

5 EU importers place this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Dimension A1C Kit	Dimension A1C Kit	`10720883`	`00630414006659`	1	On the market
Dimension Acetaminophen Flex reagent cartridge	Dimension Acetaminophen Flex reagent cartridge	`10444916`	`00842768005787`	2	On the market
Dimension AHDL Calibrator	Dimension AHDL Calibrator	`10464328`	`00842768022012`	1	On the market
Dimension Alanine Aminotransferase Flex reagent cartridge	Dimension Alanine Aminotransferase Flex reagent cartridge	`10475530`	`00842768034336`	4	On the market
Dimension Albumin Flex reagent cartridge	Dimension Albumin Flex reagent cartridge	`10444975`	`00842768005343`	4	On the market
Dimension Alkaline Phosphatase calibrator	Dimension Alkaline Phosphatase calibrator	`10714028`	`00842768039027`	1	On the market
Dimension Alkaline Phosphatase Flex reagent cartridge	Dimension Alkaline Phosphatase Flex reagent cartridge	`10642445`	`00842768039010`	4	On the market
Dimension Ammonia Flex reagent cartridge	Dimension Ammonia Flex reagent cartridge	`10711991`	`00630414948096`	4	On the market
Dimension Automated HDL Cholesterol Flex reagent cartridge	Dimension Automated HDL Cholesterol Flex reagent cartridge	`10464332`	`00842768022029`	8	On the market
Dimension Automated LDL Cholesterol Flex Reagent Cartridge	Dimension Automated LDL Cholesterol Flex Reagent Cartridge	`10444890`	`00842768005350`	4	On the market
Dimension Bilirubin Calibrator	Dimension Bilirubin Calibrator	`10445013`	`00842768016813`	1	On the market
Dimension CardioPhase high sensitivity C-reactive protein Calibrator	Dimension CardioPhase high sensitivity C-reactive protein Calibrator	`10445003`	`00842768016011`	10	On the market
Dimension CardioPhase high sensitivity CRP Flex reagent cartridge	Dimension CardioPhase high sensitivity CRP Flex reagent cartridge	`10444897`	`00842768016028`	4	On the market
Dimension Chemistry I Calibrator	Dimension Chemistry I Calibrator	`10716280`	`00630414948492`	1	On the market
Dimension Chemistry II Calibrator	Dimension Chemistry II Calibrator	`10444997`	`00842768004995`	6	On the market
Dimension Chemistry III Calibrator	Dimension Chemistry III Calibrator	`10711580`	`00630414948034`	1	On the market
Dimension CHK Flex reagent cartridge	Dimension CHK Flex reagent cartridge	`10481507`	`00842768033124`	8	On the market
Dimension CKI/MBI Calibrator	Dimension CKI/MBI Calibrator	`10464508`	`00842768025549`	1	On the market
Dimension Creatine Kinase MB Flex reagent cartridge	Dimension Creatine Kinase MB Flex reagent cartridge	`10464510`	`00842768025556`	4	On the market
Dimension Creatinine Flex reagent cartridge	Dimension Creatinine Flex reagent cartridge	`10872079`	`00630414595009`	4	On the market
Dimension Cyclosporine A Flex reagent cartridge	Dimension Cyclosporine A Flex reagent cartridge	`10285193`	`00842768025136`	4	On the market
Dimension Digitoxin Flex reagent cartridge	Dimension Digitoxin Flex reagent cartridge	`10444932`	`00842768005510`	4	On the market
Dimension Direct Bilirubin Flex reagent cartridge	Dimension Direct Bilirubin Flex reagent cartridge	`10444956`	`00842768020551`	8	On the market
Dimension Drugs of Abuse Negative Control	Dimension Drugs of Abuse Negative Control	`10445032`	`00842768005145`	6	On the market
Dimension Drugs of Abuse Positive Control	Dimension Drugs of Abuse Positive Control	`10445033`	`00842768005138`	6	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Dimension A1C Kit	Dimension A1C Kit	`10720883`	`00630414006659`	1	On the market
Dimension Acetaminophen Flex reagent cartridge	Dimension Acetaminophen Flex reagent cartridge	`10444916`	`00842768005787`	2	On the market
Dimension AHDL Calibrator	Dimension AHDL Calibrator	`10464328`	`00842768022012`	1	On the market
Dimension Alanine Aminotransferase Flex reagent cartridge	Dimension Alanine Aminotransferase Flex reagent cartridge	`10475530`	`00842768034336`	4	On the market
Dimension Albumin Flex reagent cartridge	Dimension Albumin Flex reagent cartridge	`10444975`	`00842768005343`	4	On the market
Dimension Alkaline Phosphatase calibrator	Dimension Alkaline Phosphatase calibrator	`10714028`	`00842768039027`	1	On the market
Dimension Alkaline Phosphatase Flex reagent cartridge	Dimension Alkaline Phosphatase Flex reagent cartridge	`10642445`	`00842768039010`	4	On the market
Dimension Ammonia Flex reagent cartridge	Dimension Ammonia Flex reagent cartridge	`10711991`	`00630414948096`	4	On the market
Dimension Automated HDL Cholesterol Flex reagent cartridge	Dimension Automated HDL Cholesterol Flex reagent cartridge	`10464332`	`00842768022029`	8	On the market
Dimension Automated LDL Cholesterol Flex Reagent Cartridge	Dimension Automated LDL Cholesterol Flex Reagent Cartridge	`10444890`	`00842768005350`	4	On the market
Dimension Bilirubin Calibrator	Dimension Bilirubin Calibrator	`10445013`	`00842768016813`	1	On the market
Dimension CardioPhase high sensitivity C-reactive protein Calibrator	Dimension CardioPhase high sensitivity C-reactive protein Calibrator	`10445003`	`00842768016011`	10	On the market
Dimension CardioPhase high sensitivity CRP Flex reagent cartridge	Dimension CardioPhase high sensitivity CRP Flex reagent cartridge	`10444897`	`00842768016028`	4	On the market
Dimension Chemistry I Calibrator	Dimension Chemistry I Calibrator	`10716280`	`00630414948492`	1	On the market
Dimension Chemistry II Calibrator	Dimension Chemistry II Calibrator	`10444997`	`00842768004995`	6	On the market
Dimension Chemistry III Calibrator	Dimension Chemistry III Calibrator	`10711580`	`00630414948034`	1	On the market
Dimension CHK Flex reagent cartridge	Dimension CHK Flex reagent cartridge	`10481507`	`00842768033124`	8	On the market
Dimension CKI/MBI Calibrator	Dimension CKI/MBI Calibrator	`10464508`	`00842768025549`	1	On the market
Dimension Creatine Kinase MB Flex reagent cartridge	Dimension Creatine Kinase MB Flex reagent cartridge	`10464510`	`00842768025556`	4	On the market
Dimension Creatinine Flex reagent cartridge	Dimension Creatinine Flex reagent cartridge	`10872079`	`00630414595009`	4	On the market
Dimension Cyclosporine A Flex reagent cartridge	Dimension Cyclosporine A Flex reagent cartridge	`10285193`	`00842768025136`	4	On the market
Dimension Digitoxin Flex reagent cartridge	Dimension Digitoxin Flex reagent cartridge	`10444932`	`00842768005510`	4	On the market
Dimension Direct Bilirubin Flex reagent cartridge	Dimension Direct Bilirubin Flex reagent cartridge	`10444956`	`00842768020551`	8	On the market
Dimension Drugs of Abuse Negative Control	Dimension Drugs of Abuse Negative Control	`10445032`	`00842768005145`	6	On the market
Dimension Drugs of Abuse Positive Control	Dimension Drugs of Abuse Positive Control	`10445033`	`00842768005138`	6	On the market

Siemens Healthcare Diagnostics Inc.

About Siemens Healthcare Diagnostics Inc.

Contact details for Siemens Healthcare Diagnostics Inc.

Export the 284 devices of Siemens Healthcare Diagnostics Inc.

Competent authority

Officers and regulatory representatives of Siemens Healthcare Diagnostics Inc.

Connected operators

Importers

Related searches

About Siemens Healthcare Diagnostics Inc.

Contact details for Siemens Healthcare Diagnostics Inc.

Export the 284 devices of Siemens Healthcare Diagnostics Inc.

Competent authority

Officers and regulatory representatives of Siemens Healthcare Diagnostics Inc.

Statistics for Siemens Healthcare Diagnostics Inc.

Certificate health for Siemens Healthcare Diagnostics Inc.

Related documents

Devices by risk class

Market presence of Siemens Healthcare Diagnostics Inc.

Device catalog for Siemens Healthcare Diagnostics Inc.

Device families (Basic UDI-DI) of Siemens Healthcare Diagnostics Inc.

Connected operators

Importers

Related searches

Market presence of Siemens Healthcare Diagnostics Inc.

Devices by risk class

Statistics for Siemens Healthcare Diagnostics Inc.

Certificate health for Siemens Healthcare Diagnostics Inc.

Related documents

Device catalog for Siemens Healthcare Diagnostics Inc.

Device families (Basic UDI-DI) of Siemens Healthcare Diagnostics Inc.