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Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetri…
EUDAMEDClass IVD General (EU MDR)
Ref 3015107Model R1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Calibrator: 6x0.5mLRef 3015065Model R1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Control:Low value:5x1mL High value: 5x1mLRef 3015121Model R1: 1x25mL, R2: 1x25mL,Diluent：1x55mLRef 3015120Model R1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Calibrator: 6x0.5mL, Control:Low value:5 x1mL High value: 5x1mL
Identity
- Trade Name
- Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay) EUDAMED
- Device Name
- Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- R1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Calibrator: 6x0.5mL EUDAMED3015107 EUDAMEDR1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Control:Low value:5x1mL High value: 5x1mL EUDAMED3015065 EUDAMEDR1: 1x25mL, R2: 1x25mL,Diluent：1x55mL EUDAMED3015121 EUDAMEDR1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Calibrator: 6x0.5mL, Control:Low value:5 x1mL High value: 5x1mL EUDAMED3015120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246548 EUDAMED06942202246517 EUDAMED06942202246524 EUDAMED06942202246531 EUDAMED
- Basic UDI-DI
- B-06942202246548 EUDAMEDB-06942202246517 EUDAMEDB-06942202246524 EUDAMEDB-06942202246531 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetri… by Dirui Industrial 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-06942202246548 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 57089156-123c-44c2-a301-cb5ac91d72e7 61 fields · synced Jul 16, 2026
- EUDAMED 10fce15b-39a4-4192-b6c9-e545b0ee12e9 61 fields · synced May 17, 2026
- EUDAMED e415c31b-53b5-4daa-aa6a-21664a09d0fe 61 fields · synced May 17, 2026
- EUDAMED 6d83261d-736e-463b-a755-7906791b65ca 61 fields · synced May 17, 2026