Identity
- Trade Name
- Stretch-Glide FDA UDI
- Generic Name
- Basic bed mattress FDA UDI
- Device Name
- Bed mattress. FDA UDI
- Model / Reference
- KE-798SGA FDA UDI
- Description
- Bed mattress. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04527799700158 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Basic bed mattress FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic bed mattress
Stretch-Glide by Paramount Bed Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Basic bed mattress.
- CMATT — CASCO MANUFACTURING SOLUTIONS, INC. · Class I
- Affinity® Surface — HILL-ROM, INC. · Class II
- Stretcher Surface — Hill-Rom de México, S. de R.L. de C.V. · Class II
- Stretcher Surface — Hill-Rom de México, S. de R.L. de C.V. · Class II
- CMATT — CASCO MANUFACTURING SOLUTIONS, INC. · Class I
- Accumax Surface — HILL-ROM, INC. · Class I
- CMATT — CASCO MANUFACTURING SOLUTIONS, INC. · Class I
- Centrella™ Surface — HILL-ROM, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Paramount Bed Co., Ltd.
Sources (2)
- FDA UDI 69f48a4f-110d-47f8-836a-070870eb9825 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026