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Cuvette / Cuvettes
EUDAMEDClass A (EU MDR)
Ref BSA098Ref BSA659Ref BSA046Ref BSA658Ref BSA031VSRef BSA74Ref BSA69Ref BSA096Ref BSA655Ref 04162315001 Ref BSA731Ref BSA097Ref BSA102Ref BSA86Ref BSA651 (XX73655)
Identity
- Device Name
- CUVETTE / CUVETTES EUDAMED
- Model / Reference
- BSA098 EUDAMEDBSA659 EUDAMEDBSA046 EUDAMEDBSA658 EUDAMEDBSA031VS EUDAMEDBSA74 EUDAMEDBSA69 EUDAMEDBSA096 EUDAMEDBSA655 EUDAMED04162315001 EUDAMEDBSA731 EUDAMEDBSA097 EUDAMEDBSA102 EUDAMEDBSA86 EUDAMEDBSA651 (XX73655) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033673560597 EUDAMED08033673560726 EUDAMED08033673560450 EUDAMED08033673560719 EUDAMED08033673565592 EUDAMED08033673560764 EUDAMED08033673560733 EUDAMED08033673560573 EUDAMED08033673560696 EUDAMED08033673560030 EUDAMED08033673560757 EUDAMED08033673560580 EUDAMED08033673560610 EUDAMED08033673560801 EUDAMED08033673560689 EUDAMED
- Basic UDI-DI
- 803367356CUVETTESD7 EUDAMED
- EMDN Code
- W0503010203 SAMPLES ANALYSES, PLASTIC CUVETTES EUDAMEDW050301020202 SAMPLES ANALYSES, PLASTIC MICROTUBES WITHOUT ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cuvette / Cuvettes by Biosigma S.p.a. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 803367356CUVETTESD7 | Class A | Active |
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Manufacturer
- Manufacturer
- Biosigma S.p.a.
- EUDAMED SRN
- IT-MF-000030370
Sources (15)
- EUDAMED 0c68c6c4-b7f9-4063-9739-73d206b63007 61 fields · synced Sep 30, 2026
- EUDAMED aadd0093-8254-42a4-b509-b296c719dc12 61 fields · synced May 11, 2026
- EUDAMED ce14b550-8071-4196-9738-563f7eb06167 61 fields · synced May 16, 2026
- EUDAMED dbe608ae-9d92-4714-992a-9e4d3c680dd1 61 fields · synced May 16, 2026
- EUDAMED a60dffe1-3e4f-4077-8838-ac493b3d634b 61 fields · synced May 17, 2026
- EUDAMED 1e548142-d00f-49fd-9cb0-159fe6bd5777 61 fields · synced May 17, 2026
- EUDAMED 81b32969-4971-49da-aedc-824467686d75 61 fields · synced May 17, 2026
- EUDAMED 2ece887f-b8de-4fe6-8bf6-0946fc350c01 61 fields · synced May 17, 2026
- EUDAMED 41807f74-bc52-49bd-8016-05bfb55c2dd8 61 fields · synced May 17, 2026
- EUDAMED abbf3874-3a39-4a71-9ed2-0231be1af5cd 61 fields · synced May 17, 2026
- EUDAMED e5c94a3d-8b22-4081-84e8-a842125d0a7c 61 fields · synced May 17, 2026
- EUDAMED 9992590c-461a-434c-b4fd-3f95dd054d7d 61 fields · synced May 17, 2026
- EUDAMED c33a343f-aee6-4ada-b44f-be991bec5740 61 fields · synced May 18, 2026
- EUDAMED 230d4b6f-d7b3-420c-b75b-3f4c82522914 61 fields · synced May 18, 2026
- EUDAMED 0fe0acab-c51d-413c-ba8f-427be70a82e3 61 fields · synced May 19, 2026