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As 6615 Pa Blue
EUDAMEDClass IIb (EU MDR)
Ref 0973-213-178Model AS 6615 PA BLUE
Identity
- Trade Name
- AS 6615 PA BLUE EUDAMED
- Device Name
- Steam sterilizer EUDAMED
- Model / Reference
- AS 6615 PA BLUE EUDAMED0973-213-178 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907694954501 EUDAMED
- Basic UDI-DI
- B-05907694954501 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 6615 Pa Blue 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-05907694954501 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SMS Sp. z o.o.
- EUDAMED SRN
- PL-MF-000010604
Sources (1)
- EUDAMED 4642635b-2e33-43f0-9cd6-f22e7b9bc2fd 61 fields · synced Jul 9, 2026