Identity
- Trade Name
- SAMBA III Tablet Module EUDAMED
- Device Name
- SAMBA III Tablet Module EUDAMED
- Model / Reference
- I190007TM EUDAMED
Identifiers
- Primary DI / UDI-DI
- G763I190007TM0 EUDAMED
- Basic UDI-DI
- ++G763I190007TM3C EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
SAMBA III Tablet Module by Diagnostics for the Real World (Europe) Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++G763I190007TM3C | Class A | Active |
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Manufacturer
- Manufacturer
- Diagnostics for the Real World (Europe) Ltd.
- EUDAMED SRN
- UK-MF-000047660
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED c9b7729a-c008-4d06-9918-6ef4f18d0f5f 61 fields · synced Jul 10, 2026