Identity
- Trade Name
- P50 EUDAMED
- Device Name
- Low-temperature plasma sterilizer EUDAMED
- Model / Reference
- P50 EUDAMED0973-211-110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907694954358 EUDAMED
- Basic UDI-DI
- 5907694954PS50GQ EUDAMED
- Direct Marketing DI
- 05907694954358 EUDAMED
- EMDN Code
- Z12011309 PLASMA STERILISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Category: Plasma sterilizer
P50 by SMS Sp. z o.o. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5907694954PS50GQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- SMS Sp. z o.o.
- EUDAMED SRN
- PL-MF-000010604
Sources (1)
- EUDAMED da0bb803-5c2b-46df-8a12-34ac9ce64e22 61 fields · synced Jul 15, 2026