Identity
- Trade Name
- LungCT EUDAMED
- Device Name
- LungCT/BoneCT EUDAMED
- Model / Reference
- LungCT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770020839122 EUDAMED
- Basic UDI-DI
- 37700208390006L2 EUDAMED
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
LungCT by Gleamer — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37700208390006L2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gleamer
- EUDAMED SRN
- FR-MF-000011358
Sources (1)
- EUDAMED 90758891-e16c-4b0c-8f29-81e82bbc35c2 61 fields · synced Jun 18, 2026