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Solid Bolus
EUDAMEDFDA UDIClass I (EU MDR)
Ref S-BOLUS-P1Model LT-Thermoplastic™ and Solid Bolus SeriesRef Solid Bolus (Sheets and Pellets)Model Solid Bolus Series
Identity
- Trade Name
- Solid Bolus EUDAMEDFDA UDISolid Bolus Pellets EUDAMED
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Thermoplastic Immobilization Materials and Solid Bolus EUDAMEDSolid Bolus (Sheets and Pellets) EUDAMEDSolid Bolus FDA UDI
- Model / Reference
- LT-Thermoplastic™ and Solid Bolus Series EUDAMEDS-BOLUS-P1 EUDAMEDSolid Bolus Series EUDAMEDSolid Bolus (Sheets and Pellets) EUDAMED1 FDA UDI
- Description
- Solid Bolus FDA UDI
Identifiers
- Catalog Number
- S-Bolus FDA UDI
- Primary DI / UDI-DI
- 00628341930413 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193048H EUDAMED62834193418P 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 positioning thermoplastic mould material 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
Solid Bolus 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 | 62834193048H | 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 6b1df74f-5377-435e-aa22-4fda697cdb48 61 fields · synced Jun 18, 2026
- FDA UDI 9a0bad69-1e86-45f6-9558-1d04a174534b 36 fields · synced May 30, 2026
- EUDAMED 8fb283a7-0e86-479d-9932-a036560a52fc 61 fields · synced Jun 18, 2026