Adora Accessory
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Pair of Table top side handgrips EUDAMEDAdora Accessory FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- A pair of Hand Grips for the Adora DRFi X-ray system to be fixed freely along both sides of the table for increased patient comfort. FDA UDI
- Model / Reference
- 04286390 EUDAMEDFDA UDIAdora accessories EUDAMED
- Description
- A pair of Hand Grips for the Adora DRFi X-ray system to be fixed freely along both sides of the table for increased patient comfort. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000664 EUDAMEDFDA UDI
- Basic UDI-DI
- 571346414200AP EUDAMED
- Direct Marketing DI
- 05713464000664 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
- Radiological arm/leg positioner 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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Radiological arm/leg positioner
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 Radiological arm/leg positioner.
- Immobilizer — Medtec LLC · Class II
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- Arm Support — Medtec LLC · Class II
- Elevate ArmBoard - Right Hand — Semler Technologies, Inc. · Class I
- Scancoat — DOMICO MED-DEVICE, LLC · Class II
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- Handle — Medtec LLC · Class II
- Scancoat — DOMICO MED-DEVICE, LLC · Class II
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 |
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Manufacturer
- Manufacturer
- Nrt - Nordisk Røntgen Teknik A/S
Sources (2)
- FDA UDI dc2aa38b-6f3d-489e-bf9d-938aca291dde 35 fields · synced Jul 19, 2026
- EUDAMED 2467cdf0-ba2a-4c71-b329-7af00aff78b8 61 fields · synced Jul 19, 2026