- Role
- Country
- Date of registration
- Address
MD Atlas update: Jul 11, 2026
US-MF-000023925US-MF-000023925SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →No certificates registered for this manufacturer.
ARK Diagnostics, Inc. is a medical device manufacturer registered in EUDAMED. The company has 107 devices on the EU market in United States. Headquartered in Fremont, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
Devices placed in 1 country
2 approved members
Showing 1–15 of 15 device families.
0858724003PGB0592C0858724003BZD0733F0858724003MTX026AJ70858724003MTX071AJHB-00858724003063B-00858724003124B-00858724003223B-00858724003230B-00858724003247B-00858724003339B-00858724003346B-00858724003353B-00812101030127B-00812101030134B-008121010301411 EU importer places this manufacturer's devices
1 authorised representative routes this manufacturer's devices
No documents registered for this company yet.
Showing 1–25 of 107 devices.
| Product | Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|---|
| ARK AB-PINACA Assay | ARK AB-PINACA Assay | 5055-0001-00 | 00812101030349 | 1 | On the market |
| ARK AB-PINACA Assay | ARK AB-PINACA Assay | 5055-0001-01 | 00812101030356 | 1 | On the market |
| ARK AB-PINACA Calibrator | ARK AB-PINACA Calibrator | 5055-0002-01 | 00812101030363 | 1 | On the market |
| ARK AB-PINACA Calibrator | ARK AB-PINACA Calibrator | 5055-0002-02 | 00812101030370 | 1 | On the market |
| ARK AB-PINACA Control | ARK AB-PINACA Control | 5055-0003-00 | 00812101030387 | 1 | On the market |
| ARK EDDP Assay | ARK EDDP Assay | 5051-0001-00 | 00858724003841 | 1 | On the market |
| ARK EDDP Assay | ARK EDDP Assay | 5051-0001-02 | 00858724003865 | 1 | On the market |
| ARK EDDP Assay | ARK EDDP Assay | 5051-0001-01 | 00858724003858 | 1 | On the market |
| ARK EDDP Calibrator | ARK EDDP Calibrator | 5051-0002-02 | 00858724003896 | 1 | On the market |
| ARK EDDP Calibrator | ARK EDDP Calibrator | 5051-0002-01 | 00858724003889 | 1 | On the market |
| ARK EDDP Calibrator | ARK EDDP Calibrator | 5051-0002-00 | 00858724003872 | 1 | On the market |
| ARK EDDP Calibrator | ARK EDDP Calibrator | 5051-0002-03 | 00858724003902 | 1 | On the market |
| ARK EDDP Control | ARK EDDP Control | 5051-0003-00 | 00858724003919 | 1 | On the market |
| ARK EDDP Control | ARK EDDP Control | 5051-0003-01 | 00858724003926 | 1 | On the market |
| ARK Ethyl Glucuronide Assay | ARK Ethyl Glucuronide Assay | 5036-0001-00 | 00858724003469 | 1 | On the market |
| ARK Ethyl Glucuronide Assay | ARK Ethyl Glucuronide Assay | 5036-0001-01 | 00858724003476 | 1 | On the market |
| ARK Ethyl Glucuronide Assay | ARK Ethyl Glucuronide Assay | 5036-0001-02 | 00858724003599 | 1 | On the market |
| ARK Ethyl Glucuronide Calibrator | ARK Ethyl Glucuronide Calibrator | 5036-0002-02 | 00858724003520 | 1 | On the market |
| ARK Ethyl Glucuronide Calibrator | ARK Ethyl Glucuronide Calibrator | 5036-0002-01 | 00858724003513 | 1 | On the market |
| ARK Ethyl Glucuronide Calibrator | ARK Ethyl Glucuronide Calibrator | 5036-0002-00 | 00858724003483 | 1 | On the market |
| ARK Ethyl Glucuronide Control | ARK Ethyl Glucuronide Control | 5036-0003-01 | 00858724003506 | 1 | On the market |
| ARK Ethyl Glucuronide Control | ARK Ethyl Glucuronide Control | 5036-0003-00 | 00858724003490 | 1 | On the market |
| ARK Ethyl Glucuronide II Assay | ARK Ethyl Glucuronide II Assay | 5077-0001-02 | 00812101032107 | 1 | On the market |
| ARK Ethyl Glucuronide II Assay | ARK Ethyl Glucuronide II Assay | 5077-0001-00 | 00812101032084 | 1 | On the market |
| ARK Ethyl Glucuronide II Assay | ARK Ethyl Glucuronide II Assay | 5077-0001-03 | 00812101032114 | 1 | On the market |