Charger
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- Charger FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- CHARGER MMT-7715 MDR GST3 21L IIN EUDAMEDCharger EUDAMEDCHARGER MMT-7715 MDR 21L IIN TR FDA UDI
- Model / Reference
- MMT-7715 EUDAMEDFDA UDIMMT-7512W EUDAMEDMMT-7512EEB EUDAMED
- Description
- CHARGER MMT-7715 MDR 21L IIN TR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000347659 EUDAMEDFDA UDI00763000589998 EUDAMED00763000370879 EUDAMED
- Basic UDI-DI
- 0763000B00000336V EUDAMED0763000B00000326T EUDAMED
- FDA Product Code
- OZP FDA UDI
- EMDN Code
- Z12040180 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands 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
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Charger by Medtronic Minimed, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
P120010 also covers:
- ENLITE® — MEDTRONIC MINIMED, INC.
- Enlite® Sensor — MEDTRONIC MINIMED, INC.
- Enlite® Serter — MEDTRONIC MINIMED, INC.
- Enlite™ Serter — MEDTRONIC MINIMED, INC.
- MiniLink® — MEDTRONIC MINIMED, INC.
- MiniLink® — MEDTRONIC MINIMED, INC.
- MiniLink® — MEDTRONIC MINIMED, INC.
- MiniLink® REAL-Time — MEDTRONIC MINIMED, INC.
- MiniLink® Real-Time TRANSMITTER — MEDTRONIC MINIMED, INC.
- MiniMed® 530G — MEDTRONIC MINIMED, INC.
- MiniMed® 530G — MEDTRONIC MINIMED, INC.
- MiniMed® 530G — MEDTRONIC MINIMED, INC.
P160007 also covers:
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect App — MEDTRONIC MINIMED, INC.
- Guardian™ Connect App — MEDTRONIC MINIMED, INC.
- Guardian™ Connect App — MEDTRONIC MINIMED, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Minimed, Inc.
Sources (4)
- FDA UDI 563f4a01-9839-4065-aa5d-fbdd3aaa6d35 36 fields · synced Jul 19, 2026
- EUDAMED f3d1cae6-8462-4458-b280-f13ac3eaedec 61 fields · synced Jun 14, 2026
- EUDAMED 625342f7-0a8d-4eb8-8360-65b12ba67e0b 61 fields · synced Jul 12, 2026
- EUDAMED 97ce7a50-9bd3-41f6-b944-fbaecc3722d7 61 fields · synced Jul 19, 2026