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Endotoxin LPS Control
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-5Model Type C1: R1, R2, R3 and R4 (1 pc. respectively)Model Type A4: R2 and R4 (4 pcs. respectively)Model Type B4: R1, R2 and R4 (4 pcs. respectively)Model Type A2: R2 and R4 (2 pcs. respectively)Model Type C4: R1, R2, R3 and R4 (4 pcs. respectively)
Identity
- Device Name
- Endotoxin LPS Control EUDAMED
- Model / Reference
- Type C1: R1, R2, R3 and R4 (1 pc. respectively) EUDAMEDDNK-1901-5 EUDAMEDType A4: R2 and R4 (4 pcs. respectively) EUDAMEDType B4: R1, R2 and R4 (4 pcs. respectively) EUDAMEDType A2: R2 and R4 (2 pcs. respectively) EUDAMEDType C4: R1, R2, R3 and R4 (4 pcs. respectively) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317801219 EUDAMED06930317801165 EUDAMED06930317801202 EUDAMED06930317801141 EUDAMED06930317801257 EUDAMED
- Basic UDI-DI
- B-06930317801219 EUDAMEDB-06930317801165 EUDAMEDB-06930317801202 EUDAMEDB-06930317801141 EUDAMEDB-06930317801257 EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
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
Endotoxin LPS Control by Dynamiker Biotechnology (Tianjin) 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-06930317801219 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 8b8e4b05-903c-479f-9e61-e1b11c8beb8a 61 fields · synced Jul 31, 2026
- EUDAMED 00e1fb01-d7e5-4972-8477-854cbdabc657 61 fields · synced May 17, 2026
- EUDAMED 2d40fe68-3e72-4768-a2d8-bfd0499b2cf3 61 fields · synced May 17, 2026
- EUDAMED c70f3bd7-4f9e-4b97-8fe0-859af50e84c8 61 fields · synced May 19, 2026
- EUDAMED 92e7b41d-21ce-443f-9a30-dad1f371a658 61 fields · synced May 19, 2026