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Removable Patient Control – 2 Functions
EUDAMEDFDA UDIClass I (EU MDR)
Ref FA64509-TRIModel 299-5005
Identity
- Trade Name
- REMOVABLE PATIENT CONTROL – 2 FUNCTIONS EUDAMEDFDA UDI
- Generic Name
- Bed remote control FDA UDI
- Device Name
- Control EUDAMEDA hand-operated electronic device that has a functional connection to an electrically powered medical bed to control its operation FDA UDI
- Model / Reference
- 299-5005 EUDAMEDFA64509-TRI EUDAMEDFDA UDI
- Description
- A hand-operated electronic device that has a functional connection to an electrically powered medical bed to control its operation FDA UDI
Identifiers
- Catalog Number
- FA64509-TRI FDA UDI
- Primary DI / UDI-DI
- 00670482000852 EUDAMEDFDA UDI
- Basic UDI-DI
- 67048200076PU EUDAMED
- FDA Product Code
- FNL FDA UDI
- EMDN Code
- V08068099 MEDICAL BEDS - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Bed remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5100 FDA UDI
- Market of Registration
- Ireland 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Removable Patient Control – 2 Functions 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 | 67048200076PU | 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 (2)
- EUDAMED 87930d25-968b-4d41-a58a-1a4491a189e8 61 fields · synced Oct 5, 2026
- FDA UDI cfd4d549-5b76-4887-ab1d-89939520b36b 34 fields · synced May 29, 2026