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ARK Tramadol Calibrator
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5040-0002-02Model 5040-0001-00
Identity
- Trade Name
- ARK Tramadol Calibrator EUDAMEDARK™ Tramadol Cutoff Calibrator FDA UDI
- Generic Name
- Tramadol IVD, calibrator FDA UDI
- Device Name
- ARK Tramadol Assay EUDAMEDARK™ Tramadol Cutoff Calibrator is intended for use in the calibration of the ARK™ Tramadol Assay. FDA UDI
- Model / Reference
- 5040-0001-00 EUDAMED5040-0002-02 EUDAMEDFDA UDI
- Description
- ARK™ Tramadol Cutoff Calibrator is intended for use in the calibration of the ARK™ Tramadol Assay. FDA UDI
Identifiers
- Catalog Number
- 5040-0002-02 FDA UDI
- Primary DI / UDI-DI
- 00858724003827 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003TRA0406V EUDAMED
- Direct Marketing DI
- 00858724003827 EUDAMED
- 510(k) Number
- K182280 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Tramadol 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 Tramadol 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 | 0858724003TRA0406V | 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 7c1d25f4-4884-403e-b99a-f633ed7783eb 61 fields · synced May 31, 2026
- FDA UDI 2c1b8457-f9e4-4d39-b633-ad46cc774c0e 37 fields · synced May 29, 2026