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Serum Amyloid A Protein Reagent (Immunonephelometric Method)
EUDAMEDClass IVD General (EU MDR)
Ref XQ-0010-01Model SAA II：1*13mLModel Model:SAA II Specification:1×13 mL、1×25 mL、1×45 mL、1×75 mL、1×90 mL、2×13 mL、2×25 mL、2×45 mL、2×75 mL
Identity
- Trade Name
- Serum Amyloid A Protein Reagent (Immunonephelometric Method) EUDAMED
- Device Name
- Serum Amyloid A Protein Reagent (Immunonephelometric Method) EUDAMED
- Model / Reference
- SAA II：1*13mL EUDAMEDXQ-0010-01 EUDAMEDModel:SAA II Specification:1×13 mL、1×25 mL、1×45 mL、1×75 mL、1×90 mL、2×13 mL、2×25 mL、2×45 mL、2×75 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493098942 EUDAMED
- Basic UDI-DI
- B-06970493098942 EUDAMED697049309W01023007042CP EUDAMED
- Direct Marketing DI
- 06970493098942 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
Serum Amyloid A Protein Reagent (Immunonephelometric Method) by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06970493098942 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970493098942 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED df675b6f-f1dd-4ae3-96c6-de9037b01c9c 61 fields · synced Oct 7, 2026
- EUDAMED b0992cbc-2a91-4146-97dd-e7edac0bd1a3 61 fields · synced Aug 1, 2026