Identity
- Trade Name
- AS 446 WA EUDAMED
- Device Name
- Steam sterilizer EUDAMED
- Model / Reference
- AS 446 WA EUDAMED0973-211-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907694954167 EUDAMED
- Basic UDI-DI
- B-05907694954167 EUDAMED
- EMDN Code
- Z12011304 AUTOCLAVES WITH A CHAMBER LARGER THAN OR EQUAL TO 1 STANDARD STERILISATION UNIT 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
As 446 Wa by SMS Sp. z o.o. — 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-05907694954167 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SMS Sp. z o.o.
- EUDAMED SRN
- PL-MF-000010604
Sources (1)
- EUDAMED 45ef0e2e-8713-448d-a2ba-97833bbd3fbb 61 fields · synced Jul 18, 2026