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Fibrinogen Assay Kit (Modified Clauss Method)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0003-07Model CA-FIB(L) R1: 4.0 mL× 10Ref NX-0003-02Model CA-FIB(L) R1: 4.0 mL× 10, R2: 30.0 mL× 5Ref NX-0003-09Model CA-FIB(L) 10 tests/kitRef NX-0003-10Model CA-FIB(L) 15 tests/kitRef NX-0003-11Model CA-FIB(L) 30 tests/kitRef NX-0003-04Model CA-FIB(L) R1: 4.0 mL× 1, R2: 30.0 mL× 1Ref NX-0003-01Model CA-FIB（L)：Specification 1 :R1 2.0 mL× 10, R2 5.0 mL×12Ref NX-0003-08Model CA-FIB(L) 1 test/kitRef NX-0051-01Model CA-FIB(L) Specification 1:R1: 2.0 mL× 10, R2: 5.0 mL×12Ref NX-0051-02Model CA-FIB(L) Specification 2:R1: 4.0 mL× 10, R2: 30.0 mL× 5
Identity
- Trade Name
- Fibrinogen Assay Kit (Modified Clauss Method) EUDAMED
- Device Name
- Fibrinogen Assay Kit (Modified Clauss Method) EUDAMED
- Model / Reference
- CA-FIB(L) R1: 4.0 mL× 10 EUDAMEDNX-0003-07 EUDAMEDCA-FIB(L) R1: 4.0 mL× 10, R2: 30.0 mL× 5 EUDAMEDNX-0003-02 EUDAMEDCA-FIB(L) 10 tests/kit EUDAMEDNX-0003-09 EUDAMEDCA-FIB(L) 15 tests/kit EUDAMEDNX-0003-10 EUDAMEDCA-FIB(L) 30 tests/kit EUDAMEDNX-0003-11 EUDAMEDCA-FIB(L) R1: 4.0 mL× 1, R2: 30.0 mL× 1 EUDAMEDNX-0003-04 EUDAMEDCA-FIB（L)：Specification 1 :R1 2.0 mL× 10, R2 5.0 mL×12 EUDAMEDNX-0003-01 EUDAMEDCA-FIB(L) 1 test/kit EUDAMEDNX-0003-08 EUDAMEDCA-FIB(L) Specification 1:R1: 2.0 mL× 10, R2: 5.0 mL×12 EUDAMEDNX-0051-01 EUDAMEDCA-FIB(L) Specification 2:R1: 4.0 mL× 10, R2: 30.0 mL× 5 EUDAMEDNX-0051-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451162 EUDAMED06976117451117 EUDAMED06976117451186 EUDAMED06976117451193 EUDAMED06976117451209 EUDAMED06976117451131 EUDAMED06976117451100 EUDAMED06976117451179 EUDAMED
- Basic UDI-DI
- B-06976117451162 EUDAMEDB-06976117451117 EUDAMEDB-06976117451186 EUDAMEDB-06976117451193 EUDAMEDB-06976117451209 EUDAMEDB-06976117451131 EUDAMEDB-06976117451100 EUDAMEDB-06976117451179 EUDAMED
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) 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
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
Fibrinogen Assay Kit (Modified Clauss Method) by Shenzhen Dymind Biotechnology 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-06976117451162 | 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 (10)
- EUDAMED ec3abbb6-02e8-4d6f-91d9-88b2f5082850 61 fields · synced Oct 6, 2026
- EUDAMED 70449563-3945-4d56-b5d4-1bf99e100c53 61 fields · synced May 17, 2026
- EUDAMED 29a3b31d-837e-4bd8-bfbc-26d598b2d918 61 fields · synced May 17, 2026
- EUDAMED e3c03d3f-58e5-43a3-82fd-8791545375c2 61 fields · synced May 17, 2026
- EUDAMED f7b6dd98-8eff-49ee-9956-6060381c75b9 61 fields · synced May 17, 2026
- EUDAMED 35caf15f-d7cc-4f56-a2ef-007c9dcefbf1 61 fields · synced May 17, 2026
- EUDAMED cf029b23-67b1-4479-b35b-2c5ed2905ee0 61 fields · synced May 18, 2026
- EUDAMED e59e3f84-86ce-4007-9ad0-2ff1da548265 61 fields · synced May 18, 2026
- EUDAMED f4de1342-fc82-4a7b-ab86-4228a0572add 61 fields · synced Jul 10, 2026
- EUDAMED ee7faf2a-93c4-425e-9b68-598f275e4ff1 61 fields · synced Jul 14, 2026