Geomattress
by Span-America Medical Systems, Inc. 249 variants
Ref 18352Model Geomattress Foam Mattress
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++H933GEOMATTRESSRF H93318352 | Date25 Sep 2024 | StatusActive |
| United States | GUDID listing GUDID | NumberH93318352 | Date14 Jul 2022 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Span-America
- Generic Name
- Alternating-pressure bed mattress system
- Device Name
- Geomattress
- Model / Ref / Catalog
- Geomattress Foam Mattress, 18352, GEOMATTRESS
- Primary DI / UDI-DI
- H93318352
- Basic UDI-DI
- ++H933GEOMATTRESSRF
- FDA Product Code
- IKY
- EMDN Code
- V080702 Non active anti-decubitus medical mattresses
- GMDN Term
- Alternating-pressure bed mattress system
- Device Class
- Class I
- Regulation Number
- 880.5150
- EU market of registration
- Norway
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Geomattress Foam Mattress 18352 | GEOMATTRESS |
Manufacturer details
- EUDAMED SRN
- US-MF-000002745
- Authorised representative
- Advena SRL IT-AR-000051131
Other devices from Span-America Medical Systems, Inc.
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No