Identity
- Device Name
- ARCHITECT Opiates 500 Calibrator EUDAMED
- Model / Reference
- 3L34-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884883008373 EUDAMED
- Basic UDI-DI
- B-00884883008373 EUDAMED
- EMDN Code
- W0102090113 OPIATES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ARCHITECT Opiates 500 Calibrator by Microgenics Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883008373 | Class IVD General | Active |
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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 (1)
- EUDAMED b26e407b-c853-4df0-82e3-0a689b77e0b2 61 fields · synced Jun 19, 2026