Identity
- Trade Name
- CareLink™ Personal FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- CareLink Personal Software EUDAMEDPRODUCT SFTWR MMT-7333WW PERSONAL 15.1A FDA UDI
- Model / Reference
- MMT-7333WW EUDAMEDFDA UDI
- Description
- PRODUCT SFTWR MMT-7333WW PERSONAL 15.1A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000984755 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00008748K EUDAMED
- FDA Product Code
- PHV FDA UDI
- EMDN Code
- W02079082 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2120 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Self-care monitoring/reporting software
CareLink™ Personal by Medtronic Minimed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Medtronic Minimed, Inc.
Sources (2)
- FDA UDI d0cb495c-fda8-4c53-9d5b-f6b93a1dc8f7 34 fields · synced Oct 6, 2026
- EUDAMED 4d72592e-f82f-430b-bd43-50843b229feb 61 fields · synced Jul 10, 2026