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Intelli-C Accessory
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 03282200Model CFP Accessories
Identity
- Trade Name
- Mattress, 3 cm EUDAMEDIntelli-C Accessory FDA UDI
- Generic Name
- Basic bed mattress FDA UDI
- Device Name
- Mattress, 3 cm for the Intelli-C X-ray system, for optimizing patient comfort when lying on table. FDA UDI
- Model / Reference
- 03282200 EUDAMEDFDA UDICFP Accessories EUDAMED
- Description
- Mattress, 3 cm for the Intelli-C X-ray system, for optimizing patient comfort when lying on table. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000312 EUDAMEDFDA UDI
- Basic UDI-DI
- 571346413200AG EUDAMED
- Direct Marketing DI
- 05713464000312 EUDAMED
- 510(k) Number
- K173631 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Basic bed mattress 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic bed mattress
Intelli-C 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 Basic bed mattress.
- CMATT — CASCO MANUFACTURING SOLUTIONS, INC. · Class I
- Affinity® Surface — HILL-ROM, INC. · Class II
- Stretcher Surface — Hill-Rom de México, S. de R.L. de C.V. · Class II
- Stretcher Surface — Hill-Rom de México, S. de R.L. de C.V. · Class II
- CMATT — CASCO MANUFACTURING SOLUTIONS, INC. · Class I
- Accumax Surface — HILL-ROM, INC. · Class I
- CMATT — CASCO MANUFACTURING SOLUTIONS, INC. · Class I
- Centrella™ Surface — HILL-ROM, INC. · 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 67a04c5d-e72b-4156-882f-2b2436c10cf9 35 fields · synced Jul 27, 2026
- EUDAMED 2cfbd63a-2b0b-4cf7-8d54-22acc6d267ad 61 fields · synced Jul 27, 2026