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Affera™ Integrated Mapping System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AFR-00016
Identity
- Trade Name
- Affera™ EUDAMEDAffera™ Integrated Mapping System FDA UDI
- Generic Name
- Cardiac mapping system FDA UDI
- Device Name
- Affera Integrated Mapping System EUDAMEDMAP SYS AFR-00016 IMPEDANCE US PLX FDA UDI
- Model / Reference
- AFR-00016 EUDAMEDFDA UDI
- Description
- MAP SYS AFR-00016 IMPEDANCE US PLX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000998288 EUDAMED00763000998271 FDA UDI
- Basic UDI-DI
- 0763000B00031988K EUDAMED
- 510(k) Number
- K243892 FDA UDI
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiac mapping system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac mapping system
Affera™ Integrated Mapping System by Medtronic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping system.
- Rhythmia™ Mapping System — Boston Scientific · Class II
- RHYTHMIA HDx™ — Boston Scientific · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- Rhythmia™ Mapping System — Boston Scientific · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- OptiMap™ Workstation — Cortex, Inc. · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (2)
- FDA UDI 170bea07-65ae-4d7d-a914-58b7833178a7 36 fields · synced Jul 29, 2026
- EUDAMED 313e073d-2d11-47ad-9f9e-119bb1239f0a 61 fields · synced Jul 29, 2026