Identity
- Trade Name
- DGM AND-100-2 EUDAMED
- Device Name
- Steam sterilizer EUDAMED
- Model / Reference
- DGM AND-100-2 EUDAMED0973-213-189 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907694954013 EUDAMED
- Basic UDI-DI
- B-05907694954013 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
Dgm And-100-2 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-05907694954013 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SMS Sp. z o.o.
- EUDAMED SRN
- PL-MF-000010604
Sources (1)
- EUDAMED cffe1f55-5c15-4622-9750-722b0ba0c9c2 61 fields · synced Sep 18, 2026