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Serum Amyloid A (SAA) Protein Assay Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref /Model SAA-BP, SAA-BF
Identity
- Device Name
- Serum Amyloid A (SAA) Protein Assay Kit (Nephelometry) EUDAMED
- Model / Reference
- SAA-BP, SAA-BF EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-K91201-074E EUDAMED
- Basic UDI-DI
- B-K91201-074E EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Serum Amyloid A (SAA) Protein Assay Kit (Nephelometry) by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-K91201-074E | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED a565f65c-bde4-4991-96ed-898cfc67d4b4 61 fields · synced Jul 12, 2026