Identity
- Trade Name
- Rame - Biotecnica Systems EUDAMEDRame EUDAMED
- Device Name
- Rame/Copper - Biotecnica Systems EUDAMEDRame/Copper EUDAMED
- Model / Reference
- BT3119 EUDAMED3119 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972837 EUDAMED08053172970406 EUDAMED
- Basic UDI-DI
- B-08053172972837 EUDAMEDB-08053172970406 EUDAMED
- EMDN Code
- W01010206 COPPER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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
Category: Copper IVD, reagent
Rame - Biotecnica Systems by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Copper IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Copper (Bi Reagent) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
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- Copper Colorimetric Test with Dibromo-PAESA — Kalians Corporation · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Copper - Single reagent — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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-08053172972837 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (2)
- EUDAMED c557b1d4-68c3-4077-b73c-995d85d1ff64 61 fields · synced Jul 24, 2026
- EUDAMED d42ce4a7-c43b-41ea-98a0-84fe04e13b97 61 fields · synced May 18, 2026