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DELBIO Automated Nucleic Acid Analysis System
EUDAMEDClass A (EU MDR)
Ref G1-03Ref G1-01
by Delbio Inc.
Identity
- Trade Name
- DELBIO Automated Nucleic Acid Analysis System EUDAMED
- Device Name
- Automated Nucleic Acid Analysis System EUDAMED
- Model / Reference
- G1-03 EUDAMEDG1-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713072985071 EUDAMED04713072985019 EUDAMED
- Basic UDI-DI
- 471307298G1QT EUDAMED
- Direct Marketing DI
- 04713072985071 EUDAMED04713072985019 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
DELBIO Automated Nucleic Acid Analysis System by Delbio Inc. — 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 | 471307298G1QT | Class A | Active |
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Manufacturer
- Manufacturer
- Delbio Inc.
- EUDAMED SRN
- TW-MF-000003400
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e66fb62a-d9fb-44ef-b631-aef61209faf7 61 fields · synced Aug 3, 2026
- EUDAMED 2cf6aea3-dd54-417d-ae2f-6c3da5242224 61 fields · synced May 18, 2026