Identity
- Trade Name
- UmanoLocation EUDAMEDFDA UDIUmano Connect FDA UDI
- Generic Name
- Bedside monitor remote-viewing software, non-physiological parameter FDA UDIMedical equipment non-clinical data monitoring software FDA UDI
- Device Name
- UmanoLocation EUDAMEDUmano Connect, model 282-0002, is designed to electronically receive bed status data in near real-time and display status of a connected ook bed. FDA UDIUmanoLocation is a powered module that mounts to hospital wall or ceiling a fixed location. FDA UDI
- Model / Reference
- 284-0000-TRI EUDAMEDFDA UDI282-0002 FDA UDI
- Description
- Umano Connect, model 282-0002, is designed to electronically receive bed status data in near real-time and display status of a connected ook bed. FDA UDIUmanoLocation is a powered module that mounts to hospital wall or ceiling a fixed location. FDA UDI
Identifiers
- Catalog Number
- 282-0002 FDA UDI284-0000-TRI FDA UDI
- Primary DI / UDI-DI
- 00670482000890 EUDAMEDFDA UDI00670482000814 FDA UDI
- Basic UDI-DI
- 67048200090PN EUDAMED
- FDA Product Code
- FNL FDA UDI
- EMDN Code
- V08068099 MEDICAL BEDS - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Bedside monitor remote-viewing software, non-physiological parameter FDA UDIMedical equipment non-clinical data monitoring software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5100 FDA UDI
- 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
UmanoLocation by Umano Medical 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 | 67048200090PN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Umano Medical Inc.
- EUDAMED SRN
- CA-MF-000015592
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED adf6b007-8289-4a0d-9f84-5bf42ac50442 61 fields · synced Oct 6, 2026
- FDA UDI 521d8e8c-0819-4e3f-966d-5705fa4e6930 34 fields · synced May 30, 2026
- FDA UDI 189dfed0-b880-4f1a-829b-bba1af56e076 34 fields · synced May 30, 2026