Identity
- Trade Name
- Affera™ EUDAMEDAffera™ Mapping System FDA UDI
- Generic Name
- Cardiac mapping system FDA UDI
- Device Name
- Affera Mapping System EUDAMEDMAPPING SYSTEM AFR-00003 US FDA UDI
- Model / Reference
- AFR-00003 EUDAMEDFDA UDI
- Description
- MAPPING SYSTEM AFR-00003 US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000871932 EUDAMED00763000871956 FDA UDI
- Basic UDI-DI
- 0763000B000263083 EUDAMED
- 510(k) Number
- K233943 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™ 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 12c2768f-15ff-4334-94bc-928a6d488870 36 fields · synced Jun 19, 2026
- EUDAMED 99293fd8-091e-4ade-acc1-aa42f2ed1377 61 fields · synced Jun 19, 2026