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Adora Accessory
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 04283400Model Adora accessories
Identity
- Trade Name
- Paper roll holder for patient table EUDAMEDAdora Accessory FDA UDI
- Generic Name
- Examination/treatment table paper holder FDA UDI
- Device Name
- A paper roll holder for the patient table of the Adora DRFi X-ray system. FDA UDI
- Model / Reference
- 04283400 EUDAMEDFDA UDIAdora accessories EUDAMED
- Description
- A paper roll holder for the patient table of the Adora DRFi X-ray system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000657 EUDAMEDFDA UDI
- Basic UDI-DI
- 571346414200AP EUDAMED
- Direct Marketing DI
- 05713464000657 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
- Examination/treatment table paper holder 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Examination/treatment table paper holder
Adora Accessory by Nrt - Nordisk Røntgen Teknik A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
European Union Unknown
MDR
United States Pending data
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 b831a6e8-ba24-4ffb-97fb-ffddc7dfc2f8 35 fields · synced Jun 19, 2026
- EUDAMED 66ed12ff-c0de-4205-98f4-7bcc0fc42159 61 fields · synced Jun 19, 2026