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CGM Informed Therapy Adjustment
EUDAMEDClass IIb (EU MDR)
Ref SW14553
by Dexcom
Identity
- Device Name
- CGM Informed Therapy Adjustment EUDAMED
- Model / Reference
- SW14553 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270005342 EUDAMED
- Basic UDI-DI
- 038627DEXBASAL64 EUDAMED
- EMDN Code
- Z12040292 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CGM Informed Therapy Adjustment by Dexcom — Class IIb — 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 | 038627DEXBASAL64 | Class IIb | Active |
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Manufacturer
Sources (1)
- EUDAMED 35a436a0-c57a-40c8-a1f6-f9fc0bd5932f 61 fields · synced Jul 15, 2026