Identity
- Trade Name
- SaMag-12 EUDAMED
- Device Name
- SaCycler-96R Real Time PCR System EUDAMED
- Model / Reference
- SM-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050054301235 EUDAMED
- Basic UDI-DI
- 805005430STR019A9P EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
SaMag-12 by Sacace Biotechnologies S.r.l — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 805005430STR019A9P | Class A | Active |
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Manufacturer
- Manufacturer
- Sacace Biotechnologies S.r.l
- EUDAMED SRN
- IT-MF-000031072
Sources (1)
- EUDAMED 9f5f07d1-29f9-43a4-a5c6-1178cbf29f98 61 fields · synced Jun 19, 2026