Identity
- Trade Name
- eKare inSight EUDAMEDFDA UDI
- Generic Name
- Wound measure FDA UDI
- Device Name
- eKare inSight EUDAMEDSystem for wound measurement and management. FDA UDI
- Model / Reference
- EK001 EUDAMEDFDA UDI
- Description
- System for wound measurement and management. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003459850 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600034598EK001EE EUDAMED
- Direct Marketing DI
- 00860003459850 EUDAMED
- FDA Product Code
- FXN FDA UDI
- EMDN Code
- Z11039003 MULTIFORMAT CAMERAS EUDAMED
- GMDN Term
- Wound measure FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
eKare inSight by eKare Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600034598EK001EE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- eKare Inc.
- EUDAMED SRN
- US-MF-000004864
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED eb051450-e521-4785-a69e-4240cf8cd54b 61 fields · synced Aug 4, 2026
- FDA UDI 6414509c-dfa7-4e87-8e9c-1dd145fe830a 34 fields · synced May 30, 2026