Identity
- Trade Name
- UMANO CONNECT EUDAMED
- Device Name
- Umano Connect EUDAMED
- Model / Reference
- 282-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00670482000715 EUDAMED
- Basic UDI-DI
- 67048200071PJ EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Umano Connect by Umano Medical 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 | 67048200071PJ | Class I | Active |
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Manufacturer
- Manufacturer
- Umano Medical Inc.
- EUDAMED SRN
- CA-MF-000015592
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0b91921b-1192-4f4d-bd38-b7be75fd6793 61 fields · synced Oct 7, 2026