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CRP XL Wide range
EUDAMEDClass IVD General (EU MDR)
Ref CPTXL-H00/COBRef CPTXL-L00Ref CPTXL-L00/ALIRef CPTXL-H00/AURef CPTXL-B00/COBRef CPTXL-L00/ADVRef CPTXL-L00/CGRRef CPTXL-H00/ALIRef CPTXL-B00/CGRRef CPTXL-B00/AURef CPTXL-H00Ref CPTXL-L00/AURef CPTXL-H00/ARCRef CPTXL-L00/UDARef CPTXL-L00/COBRef CPTXL-H00/ATERef CPTXL-H00/IDSRef CPTXL-B00/UDA
by Diagam S.A.
Identity
- Trade Name
- CRP XL Wide range EUDAMED
- Device Name
- CRP XL Wide range EUDAMED
- Model / Reference
- CPTXL-H00/COB EUDAMEDCPTXL-L00 EUDAMEDCPTXL-L00/ALI EUDAMEDCPTXL-H00/AU EUDAMEDCPTXL-B00/COB EUDAMEDCPTXL-L00/ADV EUDAMEDCPTXL-L00/CGR EUDAMEDCPTXL-H00/ALI EUDAMEDCPTXL-B00/CGR EUDAMEDCPTXL-B00/AU EUDAMEDCPTXL-H00 EUDAMEDCPTXL-L00/AU EUDAMEDCPTXL-H00/ARC EUDAMEDCPTXL-L00/UDA EUDAMEDCPTXL-L00/COB EUDAMEDCPTXL-H00/ATE EUDAMEDCPTXL-H00/IDS EUDAMEDCPTXL-B00/UDA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168002875 EUDAMED05415168000307 EUDAMED05415168006262 EUDAMED05415168000840 EUDAMED05415168002868 EUDAMED05415168001595 EUDAMED05415168010726 EUDAMED05415168006255 EUDAMED05415168010702 EUDAMED05415168004794 EUDAMED05415168000291 EUDAMED05415168000857 EUDAMED05415168002240 EUDAMED05415168003254 EUDAMED05415168002882 EUDAMED05415168009850 EUDAMED05415168011785 EUDAMED05415168003278 EUDAMED
- Basic UDI-DI
- B-05415168002875 EUDAMEDB-05415168000307 EUDAMEDB-05415168006262 EUDAMEDB-05415168000840 EUDAMEDB-05415168002868 EUDAMEDB-05415168001595 EUDAMEDB-05415168010726 EUDAMEDB-05415168006255 EUDAMEDB-05415168010702 EUDAMEDB-05415168004794 EUDAMEDB-05415168000291 EUDAMEDB-05415168000857 EUDAMEDB-05415168002240 EUDAMEDB-05415168003254 EUDAMEDB-05415168002882 EUDAMEDB-05415168009850 EUDAMEDB-05415168011785 EUDAMEDB-05415168003278 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
CRP XL Wide range by Diagam S.A. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-05415168002875 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (18)
- EUDAMED 7c513d4a-2e64-4801-8d42-a7e1afa96537 61 fields · synced Aug 1, 2026
- EUDAMED 15c0aa31-b06c-4c80-8724-3003374f6722 61 fields · synced May 11, 2026
- EUDAMED 3d90a8b7-2091-49ee-b552-95726b30b8cb 61 fields · synced May 16, 2026
- EUDAMED bd1d0334-c321-46cf-9212-95787a8eb885 61 fields · synced May 16, 2026
- EUDAMED d826fbe2-a246-402d-9558-45b8e346d7d2 61 fields · synced May 16, 2026
- EUDAMED cb1e936d-03aa-49bf-beb2-1a916b338e89 61 fields · synced May 17, 2026
- EUDAMED ef0f8ffb-90ba-4cef-a015-0b7e72017c9d 61 fields · synced May 17, 2026
- EUDAMED ff451224-f7fc-4233-baa4-dd48583e53fb 61 fields · synced May 17, 2026
- EUDAMED b5d84180-f00b-4721-b80e-aa5067a9b4c5 61 fields · synced May 17, 2026
- EUDAMED 30b1a3aa-9591-4b5e-aa41-556acafcb3c9 61 fields · synced May 17, 2026
- EUDAMED 985f1ee9-0c4a-4348-80a1-f4a5a6acba60 61 fields · synced May 18, 2026
- EUDAMED 1b6d1dac-bf75-4df6-b357-89b29a3fd97b 61 fields · synced May 18, 2026
- EUDAMED 02ec6360-9790-41e8-bed0-6cb572f030f7 61 fields · synced May 18, 2026
- EUDAMED e65e86a5-9d06-4a96-9e5e-3d752b1e89ca 61 fields · synced May 18, 2026
- EUDAMED a8644235-44e2-4813-b3cc-45a0da369462 61 fields · synced May 18, 2026
- EUDAMED 8c8e5500-b53b-4fc1-8b0e-542fc36de226 61 fields · synced May 18, 2026
- EUDAMED 26477fa4-c1a0-4b63-b660-8ead0e3d99e5 61 fields · synced May 18, 2026
- EUDAMED cfd32b7f-13e5-468a-8be1-d1f626b4f90f 61 fields · synced May 18, 2026