Identity
- Trade Name
- Dexcom API EUDAMEDFDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- Dexcom API EUDAMEDPublic API that allows access by authorized third parties to select Dexcom data FDA UDI
- Model / Reference
- SW13183 EUDAMEDFDA UDI
- Description
- Public API that allows access by authorized third parties to select Dexcom data FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00386270000668 EUDAMEDFDA UDI
- Basic UDI-DI
- 038627APIUC EUDAMED
- FDA Product Code
- PHV FDA UDI
- EMDN Code
- Z1204011599 BLOOD SUGAR MONITORING SYSTEMS - OTHER EUDAMED
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2120 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Dexcom API by Dexcom — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dexcom
Sources (2)
- FDA UDI 615e35ca-1bf4-41c9-ae60-5472ffe3d701 33 fields · synced Jul 29, 2026
- EUDAMED bf9b09a8-460f-4956-97f0-3b3735aca835 61 fields · synced Jul 29, 2026