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D-Dimer Control
EUDAMEDClass IVD General (EU MDR)
Ref NX-0011-03Model CAL-DD：1 × 1.0 mL/kitRef NX-0012-06Model CTRL-DD：10 × 1.0 mL (high value)Ref NX-0012-05Model CTRL-DD:10×1.0 mL (low value)Ref NX-0012-04Model Model : CTRL-DD Specification 4:10 × 0.5 mL (high value) Ref NX-0012-03Model Model : CTRL-DD Specification 3:10 × 0.5 mL (low value)
Identity
- Trade Name
- D-Dimer Control EUDAMED
- Device Name
- D-Dimer Calibrator EUDAMEDD-Dimer Control EUDAMED
- Model / Reference
- CAL-DD：1 × 1.0 mL/kit EUDAMEDNX-0011-03 EUDAMEDCTRL-DD：10 × 1.0 mL (high value) EUDAMEDNX-0012-06 EUDAMEDCTRL-DD:10×1.0 mL (low value) EUDAMEDNX-0012-05 EUDAMEDModel : CTRL-DD Specification 4:10 × 0.5 mL (high value) EUDAMEDNX-0012-04 EUDAMEDModel : CTRL-DD Specification 3:10 × 0.5 mL (low value) EUDAMEDNX-0012-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451483 EUDAMED06976117451544 EUDAMED06941377300178 EUDAMED06976117451520 EUDAMED06976117451513 EUDAMED
- Basic UDI-DI
- B-06976117451483 EUDAMEDB-06976117451544 EUDAMEDB-06941377300178 EUDAMEDB-06976117451520 EUDAMEDB-06976117451513 EUDAMED
- EMDN Code
- W0103020702 CONTROL PLASMA FOR HAEMOSTASIS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
D-Dimer Control by Shenzhen Dymind Biotechnology Co., Ltd. — 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-06976117451483 | 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 (5)
- EUDAMED cd19a173-940d-4129-934e-7f68003861e8 61 fields · synced Oct 6, 2026
- EUDAMED 91b64360-36a1-41ca-beee-738f4142dd4f 61 fields · synced May 18, 2026
- EUDAMED 83d901bf-89fe-47b4-ae50-c2217df99679 61 fields · synced May 18, 2026
- EUDAMED 9dc9cd87-40a0-45d1-b805-2ed1b4df3ab3 61 fields · synced Jul 20, 2026
- EUDAMED 129b5641-823e-47da-8435-bfda9f9a15ce 61 fields · synced Jul 28, 2026