Identity
- Trade Name
- ICM-Core 14.0.0 EUDAMED
- Model / Reference
- 207037XK29Z000 EUDAMEDMK05191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675749493 EUDAMED
- Basic UDI-DI
- 040486751207037XK29Z000GG EUDAMED
- Direct Marketing DI
- 04048675749493 EUDAMED
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ICM-Core 14.0.0 by Drägerwerk AG & Co. KGaA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 040486751207037XK29Z000GG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
- EUDAMED SRN
- DE-MF-000005329
Sources (1)
- EUDAMED f73cd49b-7e9b-4543-a405-e22daf67947c 61 fields · synced Jul 17, 2026