Identity
- Device Name
- Verification pressure chamber EUDAMED
- Model / Reference
- FU9005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594211570176 EUDAMED
- Basic UDI-DI
- 859421157APSCALIBRATORAL EUDAMED
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
Verification pressure chamber by MEDKONSULT medical technology s.r.o. — Class I — 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 | 859421157APSCALIBRATORAL | Class I | Active |
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Manufacturer
- Manufacturer
- MEDKONSULT medical technology s.r.o.
- EUDAMED SRN
- CZ-MF-000016193
Sources (1)
- EUDAMED 2bd9ea25-689b-42a2-b97d-256757218226 61 fields · synced Jun 19, 2026