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Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref SUPG272025
Identity
- Trade Name
- Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold) EUDAMED
- Device Name
- Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold) EUDAMED
- Model / Reference
- SUPG272025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521000112 EUDAMED
- Basic UDI-DI
- B-06974521000112 EUDAMED
- EMDN Code
- W0102090220 ETHYL GLUCURONIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold) by Shenzhen Superbio Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974521000112 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 6677277b-7342-473f-9edb-3710b6ccf611 61 fields · synced Jun 18, 2026