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FX 3000 type LCD19
EUDAMEDClass IIb (EU MDR)
Ref FX3000LCD19Model FX 3000 type LCD19
Identity
- Trade Name
- FX 3000 type LCD19 EUDAMED
- Device Name
- FX 3000 multi-parameter patient monitor EUDAMED
- Model / Reference
- FX 3000 type LCD19 EUDAMEDFX3000LCD19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59044737176160 EUDAMED
- Basic UDI-DI
- B-59044737176160 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 LCD19 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-59044737176160 | Class IIb | Active |
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Manufacturer
- Manufacturer
- EMTEL Śliwa spółka komandytowa
- EUDAMED SRN
- PL-MF-000006848
Sources (1)
- EUDAMED 7b98f78d-0b32-48bf-9f14-e99890cf7fac 61 fields · synced Oct 6, 2026