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ICH Bleeding Detection
EUDAMEDClass IIb (EU MDR)
Ref ICH Bleeding Detection ver. 16
Identity
- Trade Name
- ICH Bleeding Detection EUDAMED
- Device Name
- ICH Bleeding Detection EUDAMED
- Model / Reference
- ICH Bleeding Detection ver. 16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05745000308231 EUDAMED
- Basic UDI-DI
- 5745000308CMNICHYA EUDAMED
- Direct Marketing DI
- 05745000308231 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark 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
ICH Bleeding Detection by Cercare Medical A/S — Class IIb — 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 | 5745000308CMNICHYA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Cercare Medical A/S
- EUDAMED SRN
- DK-MF-000002148
Sources (1)
- EUDAMED 92e1110c-11dd-4d32-9370-71a714813ba1 61 fields · synced Jun 18, 2026