Identity
- Trade Name
- PCR-Q EUDAMED
- Device Name
- PCR-Q/CRP-Q EUDAMED
- Model / Reference
- 7782 EUDAMED7710 EUDAMED7783 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172971755 EUDAMED08053172971731 EUDAMED08053172971762 EUDAMED
- Basic UDI-DI
- B-08053172971755 EUDAMEDB-08053172971731 EUDAMEDB-08053172971762 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
No
EUDAMEDEUDAMED
Animal Tissues
Yes
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-Q 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-08053172971755 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED 7fea16d6-ad6b-4af3-b4ce-219de435b9b4 61 fields · synced Jul 23, 2026
- EUDAMED b93a2f3b-8723-46e2-bc92-3df6586622b8 61 fields · synced May 17, 2026
- EUDAMED e62df78a-1b7e-4491-ad4a-87ff27fbcd57 61 fields · synced May 17, 2026