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Intelli-C Accessory
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 03282000Model CFP Accessories
Identity
- Trade Name
- Foot Rest EUDAMEDIntelli-C Accessory FDA UDI
- Generic Name
- Footrest FDA UDI
- Device Name
- Footrest for Intelli-C X-ray system to support the patient during table top angulation. FDA UDI
- Model / Reference
- 03282000 EUDAMEDFDA UDICFP Accessories EUDAMED
- Description
- Footrest for Intelli-C X-ray system to support the patient during table top angulation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000732 EUDAMEDFDA UDI
- Basic UDI-DI
- 571346413200AG EUDAMED
- Direct Marketing DI
- 05713464000732 EUDAMED
- 510(k) Number
- K173631 FDA UDI
- FDA Product Code
- JAA FDA UDIOWB FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Footrest 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: Footrest
Intelli-C Accessory by Nrt - Nordisk Røntgen Teknik A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Footrest.
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- Jenx — JENX LIMITED · Class I
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- Jenx — JENX LIMITED · Class I
Cleared under the same submission
K173631 also covers:
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — 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 5cc7f59e-0703-48f3-9e9a-1b46acfc551e 35 fields · synced Jul 28, 2026
- EUDAMED 56ad7dec-6379-44e0-a3a3-ae2712d92615 61 fields · synced Jul 28, 2026