Identity
- Trade Name
- K-4oem EUDAMEDK-4oem AIRE-FLOAT FDA UDI
- Generic Name
- Low-air-loss bed FDA UDI
- Device Name
- K-4oem AIRE - FLOAT EUDAMEDAlternating Pressure with Low Air Loss Mattress System, 80" x 36" x 10" FDA UDI
- Model / Reference
- K-4oem EUDAMEDK-4oemMS FDA UDI
- Description
- Alternating Pressure with Low Air Loss Mattress System, 80" x 36" x 10" FDA UDI
Identifiers
- Catalog Number
- K-4oemMS FDA UDI
- Primary DI / UDI-DI
- 00817012021417 EUDAMEDFDA UDI
- Basic UDI-DI
- 081701202K4oem45 EUDAMED
- Direct Marketing DI
- 00817012021417 EUDAMED
- FDA Product Code
- FNM FDA UDI
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
- GMDN Term
- Low-air-loss bed FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5550 FDA UDI
- Market of Registration
- Belgium 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
K-4oem by Kap Medical — 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 | 081701202K4oem45 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- KAP Medical
- EUDAMED SRN
- US-MF-000007868
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 2bef49c0-21ba-4efe-a2a1-cd63677bb941 61 fields · synced May 30, 2026
- FDA UDI ecad6e0c-525f-4078-9d1d-0e256ffe22ac 35 fields · synced May 30, 2026