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[random Access Analyzer] A15
EUDAMEDClass A (EU MDR)
Ref 83105Ref 83105CRef 83105S
Identity
- Device Name
- [RANDOM ACCESS ANALYZER] A15 EUDAMED
- Model / Reference
- 83105 EUDAMED83105C EUDAMED83105S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287131055 EUDAMED08435287109986 EUDAMED08435287112092 EUDAMED
- Basic UDI-DI
- 8435287191A15000000072 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
New Device
No
EUDAMED
[random Access Analyzer] A15 by Biosystems S.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 | 8435287191A15000000072 | Class A | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED d2dc0018-10c8-44fd-a81f-042dff2fc74c 61 fields · synced Aug 3, 2026
- EUDAMED 8eb65b0d-239c-4c07-93cb-d1cf57e402f8 61 fields · synced May 17, 2026
- EUDAMED b714251b-26b1-448c-bf2e-88f6347463f7 61 fields · synced May 18, 2026