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Freedom PLUS Intuition Adapter Plate (MR Conditional)
EUDAMEDFDA UDIClass I (EU MDR)
Ref PLUS-01-KModel PLUS-01
Identity
- Trade Name
- Freedom PLUS Intuition Adapter Plate (MR Conditional) EUDAMEDFreedom FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- Freedom PLUS Intuition Adapter Plate EUDAMEDPLUS Intuition Adapter Plate (MR Conditional) FDA UDI
- Model / Reference
- PLUS-01 EUDAMEDPLUS-01-K EUDAMED1 FDA UDI
- Description
- PLUS Intuition Adapter Plate (MR Conditional) FDA UDI
Identifiers
- Catalog Number
- PLUS-K FDA UDI
- Primary DI / UDI-DI
- 00628341930369 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193118E EUDAMED
- 510(k) Number
- K122888 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- France 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
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Freedom PLUS Intuition Adapter Plate (MR Conditional) by CDR Systems Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 62834193118E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CDR Systems Inc.
- EUDAMED SRN
- CA-MF-000051790
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 486d89f9-1ba2-43cb-ada7-5b154ab35cdf 61 fields · synced Jun 20, 2026
- FDA UDI 67b8c490-b710-4036-9a10-80444cde8904 36 fields · synced May 30, 2026