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Therapeutic Drug Monitoring Control
EUDAMEDClass B (EU MDR)
Ref P11901Model 1 mL×2 (2 levels, lyophilized product)
Identity
- Trade Name
- Therapeutic Drug Monitoring Control EUDAMED
- Device Name
- Therapeutic Drug Monitoring Control EUDAMED
- Model / Reference
- 1 mL×2 (2 levels, lyophilized product) EUDAMEDP11901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293591657 EUDAMED
- Basic UDI-DI
- 697518250P119016R EUDAMED
- Direct Marketing DI
- 06942293591657 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
Therapeutic Drug Monitoring Control by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697518250P119016R | 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 f576da45-2f7b-4c11-acef-32010438405e 61 fields · synced Oct 7, 2026