Identity
- Trade Name
- oneNEST S EUDAMEDFDA UDI
- Generic Name
- Foam bed mattress FDA UDI
- Device Name
- Hybrid foam-gel mattress 303S EUDAMEDoneNEST S 80''x 35'' is a non-powered foam surface FDA UDI
- Model / Reference
- FM303S EUDAMED303-803508HS4FB-BIL EUDAMEDFDA UDI
- Description
- oneNEST S 80''x 35'' is a non-powered foam surface FDA UDI
Identifiers
- Catalog Number
- 303-803508HS4FB-BIL FDA UDI
- Primary DI / UDI-DI
- 00670482000708 EUDAMEDFDA UDI
- Basic UDI-DI
- 67048200091PQ EUDAMED
- FDA Product Code
- IKY FDA UDI
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
- GMDN Term
- Foam bed mattress FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5150 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
oneNEST S 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 | 67048200091PQ | 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 7ae1840e-50dc-46c0-a8a6-ea9327ee5351 61 fields · synced Oct 5, 2026
- FDA UDI 499e0520-8a91-4235-9b67-eedb3919c4b3 34 fields · synced May 30, 2026