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Dose Check
EUDAMEDClass IIa (EU MDR)
Ref DSC-XX-001 [XX = Refers to EU Country Code]Model DSC-xx-001, where xx is Country dependent (ex. Italy Model Number – DSC-IT-001)
Identity
- Trade Name
- Dose Check EUDAMED
- Device Name
- Dose Check EUDAMED
- Model / Reference
- DSC-xx-001, where xx is Country dependent (ex. Italy Model Number – DSC-IT-001) EUDAMEDDSC-XX-001 [XX = Refers to EU Country Code] EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860008440129 EUDAMED
- Basic UDI-DI
- 0850006610ISPXX EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
Dose Check by Amalgam Rx, Inc — 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 | 0850006610ISPXX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Amalgam Rx, Inc
- EUDAMED SRN
- US-MF-000021912
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 23023324-f0ff-42d0-9fc9-2f998f153ae8 61 fields · synced Jun 18, 2026