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RSM 2430C Choice
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref RSM 2430C ChoiceModel RSM 1824C
Identity
- Trade Name
- RSM 2430C Choice EUDAMED
- Device Name
- Flat-Panel Digital X-ray Detector EUDAMED
- Model / Reference
- RSM 1824C EUDAMEDRSM 2430C Choice EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800018409008 EUDAMED
- Basic UDI-DI
- 88000184DMXXXXXXXXW7 EUDAMED
- Direct Marketing DI
- 08800018409008 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Stationary basic diagnostic x-ray system, digital
RSM 2430C Choice by DRTECH Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170930 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000184DMXXXXXXXXW7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
- EUDAMED SRN
- KR-MF-000012441
- Authorised Representative
- DRTECH Europe GmbH DE-AR-000011974
Sources (2)
- EUDAMED 8ced46a4-9976-45d5-b466-483b337dee90 61 fields · synced Jul 20, 2026
- FDA 510(k) K170930 1 fields · synced May 18, 2026