← Back to catalogue
Serum Amyloid A (SAA) Test Kit (Immunofluorescence Method)
EUDAMEDClass IVD General (EU MDR)
Ref W-IF2-SAA-40Model 40 tests/kitRef W-IF2-SAA-20Model 20 tests/kit
Identity
- Device Name
- Serum Amyloid A (SAA) Test Kit (Immunofluorescence Method) EUDAMED
- Model / Reference
- 40 tests/kit EUDAMEDW-IF2-SAA-40 EUDAMED20 tests/kit EUDAMEDW-IF2-SAA-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896415908 EUDAMED06973720138091 EUDAMED
- Basic UDI-DI
- B-06978896415908 EUDAMEDB-06973720138091 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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) Test Kit (Immunofluorescence Method) by Wuhan Easydiagnosis Biomedicine 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-06978896415908 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 111e2146-ef81-4987-9657-33682839724c 61 fields · synced Oct 6, 2026
- EUDAMED 8d785b18-7e59-4572-a5ff-a27f8d7ae037 61 fields · synced May 17, 2026