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C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)
EUDAMEDClass IVD General (EU MDR)
Ref R1:20mL×2 R2:20mL×2(705)Ref R1:80mL×1 R2:80mL×1(706)Ref Calibrator：1mL×5(91014)Ref R1:90mL×1 R2:30mL×1(708)Ref R1:60mL×2 R2:20mL×2(701)Ref R1:60mL×5 R2:20mL×5(795)Ref R1:48mL×2 R2:16mL×2(713)
Identity
- Trade Name
- C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric) EUDAMEDC Reactive Protein (CRP) Test Kit (Immunoturbidimetric) EUDAMED
- Device Name
- C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric) EUDAMEDC Reactive Protein (CRP) Test Kit (Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:20mL×2 R2:20mL×2(705) EUDAMEDR1:80mL×1 R2:80mL×1(706) EUDAMEDCalibrator：1mL×5(91014) EUDAMEDR1:90mL×1 R2:30mL×1(708) EUDAMEDR1:60mL×2 R2:20mL×2(701) EUDAMEDR1:60mL×5 R2:20mL×5(795) EUDAMEDR1:48mL×2 R2:16mL×2(713) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674867173 EUDAMED06971674867180 EUDAMED06971674867845 EUDAMED06971674869542 EUDAMED06971674869504 EUDAMED06971674869559 EUDAMED06971674869566 EUDAMED
- Basic UDI-DI
- B-06971674867173 EUDAMEDB-06971674867180 EUDAMEDB-06971674867845 EUDAMEDB-06971674869542 EUDAMEDB-06971674869504 EUDAMEDB-06971674869559 EUDAMEDB-06971674869566 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric) by Biobase Biodustry(Shandong) 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-06971674867173 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (7)
- EUDAMED 00c91675-1dbb-41d4-adb8-98aaa03e47f4 61 fields · synced Oct 6, 2026
- EUDAMED abb0bd34-9192-432d-8907-2afaa3467285 61 fields · synced May 16, 2026
- EUDAMED 0fb7af8e-05f7-4138-9016-63a9fe65497e 61 fields · synced May 18, 2026
- EUDAMED 83d0f4d6-ea15-4488-be4b-bd6449c1fb1d 61 fields · synced Jul 10, 2026
- EUDAMED b8d03d5f-c236-427a-9e56-8657faad4a5f 61 fields · synced Jul 10, 2026
- EUDAMED 6d8fa25b-c8b1-46c6-a4c4-63fd74258470 61 fields · synced Jul 11, 2026
- EUDAMED 8b9b0915-7dd0-4752-bec5-dbc7ba330a01 61 fields · synced Jul 31, 2026