Adora Accessory
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Mattress, Comfort Transfer EUDAMEDAdora Accessory FDA UDI
- Generic Name
- Patient transfer/turning sheet, reusable FDA UDI
- Device Name
- A low-friction comfort transfer mattress used for transferring patients to the patient table of the Adora DRFi X-ray system. FDA UDI
- Model / Reference
- 04282240 EUDAMEDFDA UDIAdora accessories EUDAMED
- Description
- A low-friction comfort transfer mattress used for transferring patients to the patient table of the Adora DRFi X-ray system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000701 EUDAMEDFDA UDI
- Basic UDI-DI
- 571346414200AP EUDAMED
- Direct Marketing DI
- 05713464000701 EUDAMED
- 510(k) Number
- K242948 FDA UDI
- FDA Product Code
- JAA FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient transfer/turning sheet, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Patient transfer/turning sheet, reusable
Adora Accessory by Nrt - Nordisk Røntgen Teknik A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient transfer/turning sheet, reusable.
- Binder Lift — We Stitch Stuff, LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Binder Lift — We Stitch Stuff, LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Binder Lift — We Stitch Stuff, LLC · Class I
Cleared under the same submission
K242948 also covers:
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora DRFi — Nrt - Nordisk Røntgen Teknik A/S
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nrt - Nordisk Røntgen Teknik A/S
Sources (2)
- FDA UDI bbb0c2aa-7824-4a00-ae56-52431181b936 35 fields · synced Jul 24, 2026
- EUDAMED f60b7874-d4a6-4259-b592-1fddfa33124b 61 fields · synced Jul 24, 2026