Identity
- Trade Name
- eKare inSight RM EUDAMED
- Device Name
- eKare inSight RM EUDAMED
- Model / Reference
- IRM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00863321000247 EUDAMED
- Basic UDI-DI
- 08600034598IRMR5 EUDAMED
- EMDN Code
- Z12040102 EQUIPMENT FOR ANALYSIS OF THE PHYSIOLOGICAL PARAMETERS OF THE SKIN EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
eKare inSight RM by eKare 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 | 08600034598IRMR5 | Class I | Active |
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Manufacturer
- Manufacturer
- eKare Inc.
- EUDAMED SRN
- US-MF-000004864
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (1)
- EUDAMED 3650feb5-709b-44c9-9642-15b4fe2b4dd6 61 fields · synced Jul 10, 2026