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DRI Oxycodone Calibrator 500
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 100252Ref 05178533190
Identity
- Trade Name
- DRI Oxycodone Calibrator 500 FDA UDI
- Generic Name
- Oxycodone IVD, calibrator FDA UDI
- Device Name
- DRI Oxycodone Calibrator 500 EUDAMED
- Model / Reference
- 100252 EUDAMEDFDA UDI05178533190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884883005952 EUDAMEDFDA UDI04015630999682 EUDAMED
- Basic UDI-DI
- B-00884883005952 EUDAMEDB-04015630999682 EUDAMED
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102090123 OXYCODINE EUDAMED
- GMDN Term
- Oxycodone IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General 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
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
DRI Oxycodone Calibrator 500 by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883005952 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (3)
- EUDAMED 702d8ba5-64c5-4c79-a698-967a1c0fc540 61 fields · synced Aug 1, 2026
- FDA UDI 9e9fdf51-d9fd-4814-870e-38097f53284c 32 fields · synced May 30, 2026
- EUDAMED b291d0e2-0046-448e-8fe4-51cbf56bb798 61 fields · synced Aug 1, 2026