Identity
- Trade Name
- NavTrac-MR® Dilator Cable EUDAMED
- Device Name
- Vision-MR® Ablation Cable Set 2.0 EUDAMED
- Model / Reference
- CABTD100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854277008166 EUDAMED
- Basic UDI-DI
- 0854277008CABMR1XXMZ EUDAMED
- EMDN Code
- C0280 ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
NavTrac-MR® Dilator Cable by Imricor Medical Systems, Inc. — Class I — 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 | 0854277008CABMR1XXMZ | Class I | Active |
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Manufacturer
- Manufacturer
- Imricor Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000017310
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (1)
- EUDAMED e08140ef-0027-4710-ae16-b25703e798e5 61 fields · synced Jul 23, 2026