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FX 3000 type LCD15
EUDAMEDClass IIb (EU MDR)
Ref FX3000LCD15Model FX 3000 type LCD15
Identity
- Trade Name
- FX 3000 type LCD15 EUDAMED
- Device Name
- FX 3000 multi-parameter patient monitor EUDAMED
- Model / Reference
- FX 3000 type LCD15 EUDAMEDFX3000LCD15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59044737175934 EUDAMED
- Basic UDI-DI
- B-59044737175934 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FX 3000 type LCD15 by EMTEL Śliwa spółka komandytowa — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-59044737175934 | Class IIb | Active |
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Manufacturer
- Manufacturer
- EMTEL Śliwa spółka komandytowa
- EUDAMED SRN
- PL-MF-000006848
Sources (1)
- EUDAMED 2b305a85-f89c-407c-834c-2dae593299b0 61 fields · synced Oct 6, 2026