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Antithrombin III Testing Kit (Chromogenic Substrate Method)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0007-07Model CA AT-III (L)，R1: 7.0 mL × 4, R2: 2.0 mL × 4Ref NX-0007-08Model CA AT-III (L)，1 test/kitRef NX-0007-09Model CA AT-III (L)，10 tests/kitRef NX-0007-04Model CA AT-III (L) Specification 1：R1: 3.5 mL × 1, R2: 1.0 mL × 1, R3: 5.0 mL × 1Ref NX-0007-05Model CA AT-III (L) Specification 4：R1: 3.5 mL × 1, R2: 1.0 mL × 1Ref NX-0007-03Model Model : CA AT-III (L) Specification 9: 15 tests/kit
Identity
- Trade Name
- Antithrombin III Testing Kit (Chromogenic Substrate Method) EUDAMED
- Device Name
- Antithrombin III Testing Kit (Chromogenic Substrate Method) EUDAMED
- Model / Reference
- CA AT-III (L)，R1: 7.0 mL × 4, R2: 2.0 mL × 4 EUDAMEDNX-0007-07 EUDAMEDCA AT-III (L)，1 test/kit EUDAMEDNX-0007-08 EUDAMEDCA AT-III (L)，10 tests/kit EUDAMEDNX-0007-09 EUDAMEDCA AT-III (L) Specification 1：R1: 3.5 mL × 1, R2: 1.0 mL × 1, R3: 5.0 mL × 1 EUDAMEDNX-0007-04 EUDAMEDCA AT-III (L) Specification 4：R1: 3.5 mL × 1, R2: 1.0 mL × 1 EUDAMEDNX-0007-05 EUDAMEDModel : CA AT-III (L) Specification 9: 15 tests/kit EUDAMEDNX-0007-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117454460 EUDAMED06976117454477 EUDAMED06976117454484 EUDAMED06941377305906 EUDAMED06941377305913 EUDAMED06976117454491 EUDAMED
- Basic UDI-DI
- B-06976117454460 EUDAMEDB-06976117454477 EUDAMEDB-06976117454484 EUDAMEDB-06941377305906 EUDAMEDB-06941377305913 EUDAMEDB-06976117454491 EUDAMED
- EMDN Code
- W0103020602 ANTITHROMBIN 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
Antithrombin III Testing Kit (Chromogenic Substrate 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-06976117454460 | 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 (6)
- EUDAMED cda6f725-f8a9-49ca-9c73-7be9d798f3e4 61 fields · synced Oct 5, 2026
- EUDAMED 8db35231-e573-4c3f-8899-246da4efa63e 61 fields · synced May 17, 2026
- EUDAMED bd8f87c9-3976-473e-8278-ef3cd8988dca 61 fields · synced May 18, 2026
- EUDAMED 2d7ebc1c-f0b5-458f-9738-fe079b068385 61 fields · synced May 18, 2026
- EUDAMED 293a1f6e-0cd8-4bc3-802a-ba17e9fdd42d 61 fields · synced May 18, 2026
- EUDAMED aa21a1fa-9ef9-48eb-9c58-1a1cc6a2cd78 61 fields · synced Jul 19, 2026