← Back to catalogue
Calcio Arsenazo - Biotecnica Systems
EUDAMEDClass IVD General (EU MDR)
Ref BT0030Ref 0030Ref 0030/2
Identity
- Trade Name
- Calcio Arsenazo - Biotecnica Systems EUDAMEDCalcio Arsenazo EUDAMED
- Device Name
- Calcio Arsenazo/Calcium Arsenazo - Biotecnica Systems EUDAMEDCalcio Arsenazo/Calcium Arsenazo EUDAMED
- Model / Reference
- BT0030 EUDAMED0030 EUDAMED0030/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972646 EUDAMED08053172970215 EUDAMED08053172970185 EUDAMED
- Basic UDI-DI
- B-08053172972646 EUDAMEDB-08053172970215 EUDAMEDB-08053172970185 EUDAMED
- EMDN Code
- W01010303 CALCIUM 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
Calcio Arsenazo - Biotecnica Systems 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-08053172972646 | 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 (3)
- EUDAMED 62c852d6-d98a-4ad1-b46b-c1c0f5671b3f 61 fields · synced Jul 18, 2026
- EUDAMED bb846d43-a465-4502-9db8-175cd9a951a5 61 fields · synced May 17, 2026
- EUDAMED a9b1fd5f-d2d5-42d0-9db7-9fa1632b2120 61 fields · synced May 18, 2026