Identity
- Trade Name
- VitaSIRO solo Instrument EUDAMED
- Device Name
- VitaSIRO solo Instrument EUDAMED
- Model / Reference
- PCRAC1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878570466 EUDAMED
- Basic UDI-DI
- 471987857PCRAC1101RP EUDAMED
- Direct Marketing DI
- 04719878570466 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
VitaSIRO solo Instrument by Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch — 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 | 471987857PCRAC1101RP | Class A | Active |
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Manufacturer
- Manufacturer
- Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
- EUDAMED SRN
- TW-MF-000023414
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d60d448c-468f-4281-b501-127feddbbb45 61 fields · synced Jul 12, 2026