Identity
- Device Name
- ARCHITECT Digoxin Calibrator EUDAMED
- Model / Reference
- 1E06-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884883008199 EUDAMED
- Basic UDI-DI
- B-00884883008199 EUDAMED
- EMDN Code
- W0102080101 DIGOXIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 Digoxin 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-00884883008199 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (1)
- EUDAMED a30b7181-36e6-4fb1-b68f-dc097effc065 61 fields · synced Jul 14, 2026