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Ethyl Glucuronide 500 Qualitative Calibrator Set
EUDAMEDClass B (EU MDR)
Ref 09976485190
Identity
- Trade Name
- Ethyl Glucuronide 500 Qualitative Calibrator Set EUDAMED
- Device Name
- Ethyl Glucuronide Calibrators and Controls EUDAMED
- Model / Reference
- 09976485190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850624008612 EUDAMED
- Basic UDI-DI
- 0850624008CCEtG302HJ EUDAMED
- Direct Marketing DI
- 00850624008612 EUDAMED
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Ethyl Glucuronide 500 Qualitative Calibrator Set by Lin-Zhi International, Inc. — 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 | 0850624008CCEtG302HJ | Class B | Active |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
- EUDAMED SRN
- US-MF-000003373
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 5d6e8e1c-3d88-4fce-a04f-1287dfb6db37 61 fields · synced Oct 8, 2026