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ARK Ketamine II Calibrator
EUDAMEDClass B (EU MDR)
Ref 5083-0002-02Model 5083-0001-00
Identity
- Trade Name
- ARK Ketamine II Calibrator EUDAMED
- Device Name
- ARK Ketamine II Assay EUDAMED
- Model / Reference
- 5083-0001-00 EUDAMED5083-0002-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812101031643 EUDAMED
- Basic UDI-DI
- 0858724003KET0833G EUDAMED
- Direct Marketing DI
- 00812101031643 EUDAMED
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ARK Ketamine II Calibrator by Ark Diagnostics Inc — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0858724003KET0833G | Class B | Active |
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Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6abb042c-5910-485c-99c6-9fe113d90867 61 fields · synced Jun 19, 2026