← Back to catalogue
ARK Tramadol Calibrator
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5040-0002-01Model 5040-0001-00
Identity
- Trade Name
- ARK Tramadol Calibrator EUDAMEDARK™ Tramadol Negative Calibrator FDA UDI
- Generic Name
- Tramadol IVD, calibrator FDA UDI
- Device Name
- ARK Tramadol Assay EUDAMEDARK™ Tramadol Negative Calibrator is intended for use in the calibration of the ARK™ Tramadol Assay. FDA UDI
- Model / Reference
- 5040-0001-00 EUDAMED5040-0002-01 EUDAMEDFDA UDI
- Description
- ARK™ Tramadol Negative Calibrator is intended for use in the calibration of the ARK™ Tramadol Assay. FDA UDI
Identifiers
- Catalog Number
- 5040-0002-01 FDA UDI
- Primary DI / UDI-DI
- 00858724003810 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003TRA0406V EUDAMED
- Direct Marketing DI
- 00858724003810 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1afdbf9b-fe93-4d66-b552-2721fb2de0fe 61 fields · synced Jul 20, 2026
- FDA UDI a1c529c6-8bd7-487d-b4d7-03f83e5aebba 37 fields · synced May 29, 2026