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RamSoft Gateway
EUDAMEDClass I (EU MDR)
Ref QCRef MAMMORef ROUTER
by RamSoft Inc.
Identity
- Device Name
- RamSoft Gateway EUDAMED
- Model / Reference
- QC EUDAMEDMAMMO EUDAMEDROUTER EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Gateway-QC38 EUDAMEDD-Gateway-MAMMOR2 EUDAMEDD-Gateway-ROUTER8G EUDAMED
- Basic UDI-DI
- B-Gateway-QC38 EUDAMEDB-Gateway-MAMMOR2 EUDAMEDB-Gateway-ROUTER8G EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany 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
RamSoft Gateway by Ramsoft Inc — Class I — 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-Gateway-QC38 | Class I | Active |
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Manufacturer
- Manufacturer
- RamSoft Inc.
- EUDAMED SRN
- CA-MF-000038450
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (3)
- EUDAMED 65f8e298-5d08-4184-b591-d46bb7e907e6 61 fields · synced Jul 15, 2026
- EUDAMED be105ec7-6012-4937-977c-f1d1131dffc5 61 fields · synced May 18, 2026
- EUDAMED 634598a2-e4dc-41b6-93bb-de202a8dc1b8 61 fields · synced Jul 15, 2026