← Back to catalogue
FreedomX Roll Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Ref BM02-TModel FreedomX / Equilibrium / SaBella Flex Series
Identity
- Trade Name
- FreedomX Roll Adapter EUDAMEDFreedom FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Precision Patient Positioning Systems EUDAMEDRoll Adapter EUDAMEDFDA UDI
- Model / Reference
- FreedomX / Equilibrium / SaBella Flex Series EUDAMEDBM02-T EUDAMED1 FDA UDI
- Description
- Roll Adapter FDA UDI
Identifiers
- Catalog Number
- BM02-T FDA UDI
- Primary DI / UDI-DI
- 00628341930208 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193018B EUDAMED62834193228K EUDAMED
- 510(k) Number
- K122888 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system 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
FreedomX Roll Adapter 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 | 62834193018B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CDR Systems Inc.
- EUDAMED SRN
- CA-MF-000051790
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED fdc355a6-4b99-4ab5-9ed9-7feea2c2cbea 61 fields · synced Jul 13, 2026
- FDA UDI 1d23b842-dcd3-4307-be05-7c515afcb781 36 fields · synced May 29, 2026
- EUDAMED f6a1e08a-caf1-4854-aa12-bbee53539fc8 61 fields · synced Jul 13, 2026