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Lupus Anticoagulants Control
EUDAMEDClass IVD General (EU MDR)
Ref NX-0036-03Model CTRL-LA Specification 2: 1 × 1.0 mL (Positive)Ref NX-0036-03 Model CTRL-LA Specification 2：1 × 1.0 mL (Positive)
Identity
- Trade Name
- Lupus Anticoagulants Control EUDAMEDLupus Anticoagulant Control EUDAMED
- Device Name
- Lupus Anticoagulants Control EUDAMEDLupus Anticoagulant Control EUDAMED
- Model / Reference
- CTRL-LA Specification 2: 1 × 1.0 mL (Positive) EUDAMEDNX-0036-03 EUDAMEDCTRL-LA Specification 2：1 × 1.0 mL (Positive) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377306026 EUDAMED
- Basic UDI-DI
- B-06941377306026 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
EUDAMED
Animal Tissues
No
EUDAMED
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
Lupus Anticoagulants 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-06941377306026 | 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 (2)
- EUDAMED 7540b3b0-af60-403f-96a4-78e6267efa40 61 fields · synced Oct 6, 2026
- EUDAMED dbc323a6-c1d8-47ed-ad52-eebf25163a33 61 fields · synced Jun 18, 2026