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Lupus Anticoagulants Control
EUDAMEDClass IVD General (EU MDR)
Ref NX-0036-08Model CTRL-LA Specification 3: 10 × 1.0 mL (Negetive)Ref NX-0036-04Model CTRL-LA Specification 1: 1 × 1.0 mL (Negative)Ref NX-0036-08Model CTRL-LA Specification 3：10 × 1.0 mL (Negative)Ref NX-0036-04 Model CTRL-LA Specification 1：1 × 1.0 mL (Negative)
Identity
- Trade Name
- Lupus Anticoagulants Control EUDAMEDLupus Anticoagulant Control EUDAMED
- Device Name
- Lupus Anticoagulants Control EUDAMEDLupus Anticoagulant Control EUDAMED
- Model / Reference
- CTRL-LA Specification 3: 10 × 1.0 mL (Negetive) EUDAMEDNX-0036-08 EUDAMEDCTRL-LA Specification 1: 1 × 1.0 mL (Negative) EUDAMEDNX-0036-04 EUDAMEDCTRL-LA Specification 3：10 × 1.0 mL (Negative) EUDAMEDCTRL-LA Specification 1：1 × 1.0 mL (Negative) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377305142 EUDAMED06941377306019 EUDAMED
- Basic UDI-DI
- B-06941377305142 EUDAMEDB-06941377306019 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-06941377305142 | 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 (4)
- EUDAMED 68615d87-e6fe-4b8a-a92a-8abde7ccd4b2 61 fields · synced Oct 6, 2026
- EUDAMED d1d505f4-3ad9-479b-8593-f6242ca9327e 61 fields · synced May 18, 2026
- EUDAMED b90b1696-9443-4cc5-b683-aadf16954e20 61 fields · synced Jul 9, 2026
- EUDAMED 8ed0b3eb-5931-4068-9da1-ac17c23a74a4 61 fields · synced Jul 30, 2026