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Koilia Mikros Belly Board
EUDAMEDFDA UDIClass I (EU MDR)
Ref BB09 SeriesModel FreedomX / Equilibrium / SaBella Flex SeriesModel BB09 Belly Board Series
Identity
- Trade Name
- Koilia Mikros Belly Board EUDAMEDKoilia Mikros FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Precision Patient Positioning Systems EUDAMEDKoilia Mikros Belly Board EUDAMEDFDA UDI
- Model / Reference
- FreedomX / Equilibrium / SaBella Flex Series EUDAMEDBB09 Series EUDAMEDBB09 Belly Board Series EUDAMED1 FDA UDI
- Description
- Koilia Mikros Belly Board FDA UDI
Identifiers
- Catalog Number
- BB09-D FDA UDI
- Primary DI / UDI-DI
- 00628341930307 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193018B EUDAMED62834193358U 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
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
No
FDA UDI
Koilia Mikros Belly Board 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 |
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Manufacturer
- Manufacturer
- CDR Systems Inc.
- EUDAMED SRN
- CA-MF-000051790
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 148b3a0a-cb35-4cea-81cd-0c7f0ce4dca6 61 fields · synced Jun 18, 2026
- FDA UDI 55125cb6-ec26-4e19-9ecb-b08cb55025cb 36 fields · synced May 30, 2026
- EUDAMED 705a0ffc-9f9b-4afd-84d8-dee32226b4df 61 fields · synced Jun 18, 2026