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NorthStar Mapping System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref MAP01510(k) K252164
Identity
- Trade Name
- NorthStar Mapping System EUDAMED
- Device Name
- NorthStar Mapping System EUDAMED
- Model / Reference
- MAP01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854277008197 EUDAMED
- Basic UDI-DI
- 0854277008MAPXX69 EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
NorthStar Mapping System by Imricor Medical Systems, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252164 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0854277008MAPXX69 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Imricor Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000017310
- FDA Applicant
- Imricor Medical Systems
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (2)
- EUDAMED 6c8e1b8d-7d9c-465d-b47f-94927162bece 85 fields · synced Jun 19, 2026
- FDA 510(k) K252164 1 fields · synced May 18, 2026