Identity
- Trade Name
- PCR Slide EUDAMED
- Device Name
- PCR Slide EUDAMED
- Model / Reference
- 7703 EUDAMED7704 EUDAMED7789 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172971403 EUDAMED08053172971427 EUDAMED08053172971434 EUDAMED
- Basic UDI-DI
- B-08053172971403 EUDAMEDB-08053172971427 EUDAMEDB-08053172971434 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
PCR Slide by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08053172971403 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED e4f418a9-c577-4566-bfb9-5da9418c571a 61 fields · synced Jul 30, 2026
- EUDAMED 4ce9eaf0-5387-45f9-8a2d-e87c1d4d40f3 61 fields · synced May 17, 2026
- EUDAMED d9400718-f835-44a9-9222-64ba3fddfd58 61 fields · synced May 18, 2026