Identity
- Trade Name
- GS1 Microlab Nimbus EUDAMED
- Device Name
- GS1 Microlab Nimbus EUDAMED
- Model / Reference
- S-51476-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09351179090028 EUDAMED
- Basic UDI-DI
- 93511790GS1XZ EUDAMED
- EMDN Code
- W02060180 ROBOTIC SAMPLE PROCESSING SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
GS1 Microlab Nimbus by Genetic Signatures Ltd — 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 | 93511790GS1XZ | Class A | Active |
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Manufacturer
- Manufacturer
- Genetic Signatures Ltd
- EUDAMED SRN
- AU-MF-000030901
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED b1f1d614-7fbb-4fc0-a26b-9a562e676d44 61 fields · synced Jul 11, 2026