Identity
- Trade Name
- PSP® SalivaGene DNA Kit (250) EUDAMED
- Device Name
- PSP® SalivaGene DNA Kit EUDAMED
- Model / Reference
- 1035200300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600236235259 EUDAMED
- Basic UDI-DI
- 5600236235AA008EF EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
PSP® SalivaGene DNA Kit (250) by ALS Life Sciences Portugal, S.A. — 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 | 5600236235AA008EF | Class A | Active |
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Manufacturer
- Manufacturer
- ALS Life Sciences Portugal, S.A.
- EUDAMED SRN
- PT-MF-000034751
Sources (1)
- EUDAMED 0979f5da-5a08-4745-bc34-75f8c437bb10 61 fields · synced Sep 17, 2026