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C-Reactive Protein (CRP) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32026009Model 25 testsRef 32080009Ref 32027009Ref 32026146Ref 32028009Ref 32028150Ref 32027155Model 2*25 tests
Identity
- Trade Name
- C-Reactive Protein (CRP) Detection Kit (Nephelometry) EUDAMEDC-Reactive Protein (CRP) Detection Kit (Nephelometry) EUDAMEDC-Reactive Protein (CRP)Detection Kit(Nephelometry) EUDAMED
- Device Name
- C-Reactive Protein (CRP) Detection Kit (Nephelometry) EUDAMEDC-Reactive Protein (CRP) Detection Kit (Nephelometry) EUDAMEDC-Reactive Protein (CRP)Detection Kit(Nephelometry) EUDAMED
- Model / Reference
- 25 tests EUDAMED32026009 EUDAMED32080009 EUDAMED32027009 EUDAMED32026146 EUDAMED32028009 EUDAMED32028150 EUDAMED32027155 EUDAMED2*25 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-PA000455 EUDAMED06950334802235 EUDAMED06950334804222 EUDAMED06950334804239 EUDAMED06950334821496 EUDAMED06950334804246 EUDAMED06950334821526 EUDAMED06950334821519 EUDAMEDD-PA000353 EUDAMED
- Basic UDI-DI
- B-PA000455 EUDAMED69503348PA042HZ EUDAMEDB-PA000353 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- France EUDAMEDBulgaria 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
New Device
No
EUDAMED
C-Reactive Protein (CRP) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-PA000455 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-PA000455 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (10)
- EUDAMED 964a40ca-0018-4787-8920-ef4d40ea4bec 61 fields · synced Jul 29, 2026
- EUDAMED f90de6a8-192a-46f6-8f2b-dc2120db344a 61 fields · synced May 16, 2026
- EUDAMED 89f92f40-2ca4-4f88-95a3-beddaf3dbbee 61 fields · synced May 17, 2026
- EUDAMED 29519b04-30e9-42a4-8891-c64ed03eb1a3 61 fields · synced May 17, 2026
- EUDAMED 078b2278-ada6-44ef-b2f9-2761c405c702 61 fields · synced May 17, 2026
- EUDAMED c5d7f1fd-3bea-44ce-b505-9232bdb8587c 61 fields · synced May 18, 2026
- EUDAMED 3bd092ed-4117-43b4-8b31-8c721cec5201 61 fields · synced May 19, 2026
- EUDAMED dfb9bc52-1153-4889-9bd3-bbb7a826617b 61 fields · synced May 19, 2026
- EUDAMED 8a15ce39-8e7f-419d-957f-4db27704bc49 61 fields · synced May 19, 2026
- EUDAMED 246809fb-be60-4d46-a6eb-7c00fa67110d 61 fields · synced Jul 26, 2026