Identity
- Trade Name
- TMB-Substrat/Substrate ELISA EUDAMED
- Device Name
- TMB-Substrat/Substrate ELISA EUDAMED
- Model / Reference
- 151101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ENTI15110105 EUDAMED
- Basic UDI-DI
- ++ENTI151101V03PH EUDAMED
- EMDN Code
- W0105900201 BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
TMB-Substrat/Substrate ELISA by Gold Standard Diagnostics Frankfurt GmbH — Class A — 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 | ++ENTI151101V03PH | Class A | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics Frankfurt GmbH
- EUDAMED SRN
- DE-MF-000025020
Sources (1)
- EUDAMED 8026c88b-c801-43d1-ad35-da1db7ae6177 61 fields · synced Jun 18, 2026