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Whole Blood Therapeutic Drug Monitoring Control
EUDAMEDClass B (EU MDR)
Ref P11907Model 1 mL×2 (2 levels, lyophilized product)
Identity
- Trade Name
- Whole Blood Therapeutic Drug Monitoring Control EUDAMED
- Device Name
- Whole Blood Therapeutic Drug Monitoring Control EUDAMED
- Model / Reference
- 1 mL×2 (2 levels, lyophilized product) EUDAMEDP11907 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293591688 EUDAMED
- Basic UDI-DI
- 697518250P1190775 EUDAMED
- Direct Marketing DI
- 06942293591688 EUDAMED
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Whole Blood Therapeutic Drug Monitoring Control by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P1190775 | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 1bf404d1-668e-49d7-8a8e-d03379d871ce 61 fields · synced Oct 5, 2026