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ARK Fentanyl Calibrator
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5031-0002-02Model 5069-0001-00
Identity
- Trade Name
- ARK Fentanyl Calibrator EUDAMEDARK™ Fentanyl Cutoff Calibrator FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, calibrator FDA UDI
- Device Name
- ARK Fentanyl II Assay EUDAMEDARK™ Fentanyl Cutoff Calibrator is intended for use in the calibration of the ARK™ Fentanyl Assay. FDA UDI
- Model / Reference
- 5069-0001-00 EUDAMED5031-0002-02 EUDAMEDFDA UDI
- Description
- ARK™ Fentanyl Cutoff Calibrator is intended for use in the calibration of the ARK™ Fentanyl Assay. FDA UDI
Identifiers
- Catalog Number
- 5031-0002-02 FDA UDI
- Primary DI / UDI-DI
- 00858724003452 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003FEN069Y8 EUDAMED
- Direct Marketing DI
- 00858724003452 EUDAMED
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Opiate/opiate metabolite IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ARK Fentanyl Calibrator by Ark Diagnostics Inc — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0858724003FEN069Y8 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1b724b81-0fb9-409a-8961-bdd4ca501f81 61 fields · synced Jul 28, 2026
- FDA UDI 95c7e91e-3db3-47d9-9df8-707a862f8cd4 36 fields · synced May 29, 2026