Identity
- Trade Name
- Advantage-MR™ EP Recorder/Stimulator EUDAMED
- Device Name
- Advantage-MR™ EP Recorder/Stimulator System EUDAMED
- Model / Reference
- AD900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854277008203 EUDAMED
- Basic UDI-DI
- 0854277008ADXXX42 EUDAMED
- Direct Marketing DI
- 00854277008203 EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Advantage-MR™ EP Recorder/Stimulator by Imricor Medical Systems, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0854277008ADXXX42 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imricor Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000017310
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (1)
- EUDAMED 550f5cc7-e2dd-4d59-842f-b1c08c18fdb2 61 fields · synced Jun 18, 2026