Identity
- Trade Name
- Soluscope™ GTA EUDAMED
- Device Name
- Soluscope™ GTA 4X5L EUDAMED
- Model / Reference
- 2484447FG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03597610448515 EUDAMED
- Basic UDI-DI
- B-03597610448515 EUDAMED
- EMDN Code
- D01010102 GLUTARALDEHYDE, ACIDIC SOLUTION FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Soluscope™ GTA by Soluscope SAS — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03597610448515 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Soluscope SAS
- EUDAMED SRN
- FR-MF-000011763
Sources (1)
- EUDAMED 843cf466-c485-4d33-a46c-7b3ff49da361 61 fields · synced Jun 19, 2026