Adora Accessory
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Patient table support for Patient CPR EUDAMEDAdora Accessory FDA UDI
- Generic Name
- Medical table top floor stand, non-powered FDA UDI
- Device Name
- Patient table support for Patient CPR For the Adora DRFi X-ray system. A table stabilizer intended to give support to the patient table in case of emergency CPR purposes. FDA UDI
- Model / Reference
- 04289500 EUDAMEDFDA UDIAdora accessories EUDAMED
- Description
- Patient table support for Patient CPR For the Adora DRFi X-ray system. A table stabilizer intended to give support to the patient table in case of emergency CPR purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000695 EUDAMEDFDA UDI
- Basic UDI-DI
- 571346414200AP EUDAMED
- Direct Marketing DI
- 05713464000695 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
- Medical table top floor stand, non-powered 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: Medical table top floor stand, non-powered
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 Medical table top floor stand, non-powered.
- support rod — Skytron, LLC · Class I
- LEG ASSEMBLY, HAND SURGERY TABLE, REFURB — Mizuho Orthopedic Systems, Inc. · Class I
- support rod — Skytron, LLC · Class I
- Support bar — Maquet, Inc. · Class I
- TRANSFER BOARD SUPPORT ROD — Skytron, LLC · Class I
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S · 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 88e8bb87-53e6-4d51-b771-bf1740b9fa12 35 fields · synced Jul 13, 2026
- EUDAMED b8e5f51a-0a71-432f-a022-bf3ff2cf4698 61 fields · synced Jul 13, 2026