← Back to catalogue
ARK EDDP Control
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5051-0003-01Model 5051-0001-00
Identity
- Trade Name
- ARK EDDP Control EUDAMEDARK™ EDDP Control (225/375) FDA UDI
- Generic Name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control FDA UDI
- Device Name
- ARK EDDP Assay EUDAMEDARK™ EDDP Control is intended for use in quality control of the ARK™ EDDP Assay. FDA UDI
- Model / Reference
- 5051-0001-00 EUDAMED5051-0003-01 EUDAMEDFDA UDI
- Description
- ARK™ EDDP Control is intended for use in quality control of the ARK™ EDDP Assay. FDA UDI
Identifiers
- Catalog Number
- 5051-0003-01 FDA UDI
- Primary DI / UDI-DI
- 00858724003926 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003EDDP0515Z EUDAMED
- Direct Marketing DI
- 00858724003926 EUDAMED
- 510(k) Number
- K182779 FDA UDI
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152009 CONTROLS FOR NARCOTICS / TOXICOLOGY EUDAMED
- GMDN Term
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 EDDP 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 | 0858724003EDDP0515Z | 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 6e34c51f-028f-43cd-9817-343f3fe3ff79 61 fields · synced Jul 15, 2026
- FDA UDI d0c0a913-a213-4107-9b0e-2f6feb29ec59 37 fields · synced May 30, 2026