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Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry)

EUDAMED

Class IVD General (EU MDR)

Ref NX-0006-09Model CA-FDP，10 tests/kitRef NX-0006-04Model CA-FDP，R1: 2.0 mL × 1, R2: 2.0 mL × 1, R3: 2.0 mL × 1Ref NX-0006-10Model CA-FDP，30 test/kitRef NX-0006-01Model CA-FDP，R1: 4 × 2.0 mL, R2: 4 × 2.0 mL, R3: 2 × 2.0 mLRef NX-0006-07Model CA-FDP，R1: 4.0 mL × 4, R2: 4.0 mL × 4Ref NX-0006-08Model CA-FDP，1 test/kitRef NX-0006-02Model Model : CA-FDP Specification 3:R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) EUDAMED
Fibrin and Fibrinogen Degradation Products Assay Kit（Immunoturbidimetry） EUDAMED
Device Name
Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) EUDAMED
Fibrin and Fibrinogen Degradation Products Assay Kit（Immunoturbidimetry） EUDAMED
Model / Reference
CA-FDP，10 tests/kit EUDAMED
NX-0006-09 EUDAMED
CA-FDP，R1: 2.0 mL × 1, R2: 2.0 mL × 1, R3: 2.0 mL × 1 EUDAMED
NX-0006-04 EUDAMED
CA-FDP，30 test/kit EUDAMED
NX-0006-10 EUDAMED
CA-FDP，R1: 4 × 2.0 mL, R2: 4 × 2.0 mL, R3: 2 × 2.0 mL EUDAMED
NX-0006-01 EUDAMED
CA-FDP，R1: 4.0 mL × 4, R2: 4.0 mL × 4 EUDAMED
NX-0006-07 EUDAMED
CA-FDP，1 test/kit EUDAMED
NX-0006-08 EUDAMED
Model : CA-FDP Specification 3:R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL EUDAMED
NX-0006-02 EUDAMED

Identifiers

Primary DI / UDI-DI
06976117454385 EUDAMED
06976117454316 EUDAMED
06941377300222 EUDAMED
06976117454736 EUDAMED
06976117454361 EUDAMED
06976117454378 EUDAMED
06976117454743 EUDAMED
Basic UDI-DI
B-06976117454385 EUDAMED
B-06976117454316 EUDAMED
B-06941377300222 EUDAMED
B-06976117454736 EUDAMED
B-06976117454361 EUDAMED
B-06976117454378 EUDAMED
B-06976117454743 EUDAMED
EMDN Code
W0103020502 FIBRINOGEN DEGRADATION PRODUCTS 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

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 and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen Dymind Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000024842
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (7)

  • EUDAMED 5a65c643-86c9-4d1b-a1e1-816c6b82ba89 61 fields · synced Oct 6, 2026
  • EUDAMED 7cb5e5ae-7854-4ddb-843f-ce240fa8ab5d 61 fields · synced May 17, 2026
  • EUDAMED 6311b8bf-19fe-45a6-95af-c3bbec943010 61 fields · synced May 17, 2026
  • EUDAMED 1b51e18d-9a4e-469b-b638-12b5504a248d 61 fields · synced May 18, 2026
  • EUDAMED 82ce7f4e-af51-4969-92e5-4508467dd4d0 61 fields · synced May 18, 2026
  • EUDAMED f99fb30c-2db1-4ee4-b813-8bc48ddd1873 61 fields · synced May 18, 2026
  • EUDAMED dc52f4af-14d1-4a1b-b65e-285da29aaa85 61 fields · synced Jul 9, 2026