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SAA Assay Kit CLIA
EUDAMEDClass IVD General (EU MDR)
Ref SUPM045072Ref SUPM045036
Identity
- Trade Name
- SAA Assay Kit CLIA EUDAMED
- Device Name
- SAA Assay Kit CLIA EUDAMED
- Model / Reference
- SUPM045072 EUDAMEDSUPM045036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521004394 EUDAMED06974521004387 EUDAMED
- Basic UDI-DI
- B-06974521004394 EUDAMEDB-06974521004387 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
SAA Assay Kit CLIA by Shenzhen Superbio Technology Co., Ltd. — 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-06974521004394 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 8686c058-a979-469e-ba52-aba375a28a9f 61 fields · synced Jul 29, 2026
- EUDAMED 53155901-5cf1-427b-a221-e895011b0665 61 fields · synced May 18, 2026