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Custom Liquid Therapeutic Drug Control - Level 1
EUDAMEDClass B (EU MDR)
Ref HD3145
Identity
- Trade Name
- CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 1 EUDAMED
- Device Name
- CUSTOM LIQUID THERAPEUTIC DRUG CONTROL EUDAMED
- Model / Reference
- HD3145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273217315 EUDAMED
- Basic UDI-DI
- 50552732BLTDCON177KM EUDAMED
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
No
EUDAMED
Custom Liquid Therapeutic Drug Control - Level 1 by Randox Laboratories Limited — 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 | 50552732BLTDCON177KM | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED 4bac1672-6313-48f7-966a-7d8e509c1a49 61 fields · synced Jul 13, 2026