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ARK Tramadol Control
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5040-0003-00Model 5040-0001-00
Identity
- Trade Name
- ARK Tramadol Control EUDAMEDARK™ Tramadol Control FDA UDI
- Generic Name
- Tramadol IVD, control FDA UDI
- Device Name
- ARK Tramadol Assay EUDAMEDARK™ Tramadol Control is intended for use in quality control of the ARK™ Tramadol Assay. FDA UDI
- Model / Reference
- 5040-0001-00 EUDAMED5040-0003-00 EUDAMEDFDA UDI
- Description
- ARK™ Tramadol Control is intended for use in quality control of the ARK™ Tramadol Assay. FDA UDI
Identifiers
- Catalog Number
- 5040-0003-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003834 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003TRA0406V EUDAMED
- Direct Marketing DI
- 00858724003834 EUDAMED
- 510(k) Number
- K182280 FDA UDI
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152009 CONTROLS FOR NARCOTICS / TOXICOLOGY EUDAMED
- GMDN Term
- Tramadol IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 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 Control 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 40b083b1-72b9-4a2e-91c3-e6e3356da171 61 fields · synced Jul 14, 2026
- FDA UDI e8d2aafe-b5dd-4b1b-9021-2d5d6ad20f5d 37 fields · synced May 30, 2026