Identity
- Trade Name
- Fosforo UV - Biotecnica System EUDAMED
- Device Name
- Fosforo UV/Phosphorus UV - Biotecnica Systems EUDAMED
- Model / Reference
- BT0031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972653 EUDAMED
- Basic UDI-DI
- B-08053172972653 EUDAMED
- EMDN Code
- W01010307 PHOSPHATE INORGANIC / PHOSPHORUS 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: Inorganic phosphate (PO43-) IVD, reagent
Fosforo UV - Biotecnica System by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Inorganic phosphate (PO43-) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Phosphorus UV, 2 x 100 mL — Chronolab Systems, S.L. · IVD General
- Liquick Cor-PHOSPHORUS 30 — PZ CORMAY Spółka Akcyjna · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Pointe Scientific, Inc. Phosphorus — POINTE SCIENTIFIC, INC. · Class I
- ACCENT-300 PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
- Alinity — Abbott · Class I
- OS-PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
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-08053172972653 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (1)
- EUDAMED 011674d8-ec67-4dfa-9286-8adfd5775efe 61 fields · synced Jul 31, 2026