← Back to catalogue
LT-Thermoplastic™
EUDAMEDFDA UDIClass I (EU MDR)
Ref Multiple catalogue numbers in ThermoplasticModel LT-Thermoplastic™ and Solid Bolus SeriesRef Thermoplastic SeriesModel LT-Thermoplastic™ Series
Identity
- Trade Name
- LT-Thermoplastic™ EUDAMEDThermoplastic FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Thermoplastic Immobilization Materials and Solid Bolus EUDAMEDThermoplastic Immobilization Materials (CDR) EUDAMEDThermoplastic Immobilization Materials FDA UDI
- Model / Reference
- LT-Thermoplastic™ and Solid Bolus Series EUDAMEDMultiple catalogue numbers in Thermoplastic EUDAMEDLT-Thermoplastic™ Series EUDAMEDThermoplastic Series EUDAMED1 FDA UDI
- Description
- Thermoplastic Immobilization Materials FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628341930222 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193048H 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
Yes
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
LT-Thermoplastic™ 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 |
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 8b6bea14-1f62-482a-ad72-25e58855e643 61 fields · synced Jun 18, 2026
- FDA UDI 00c978da-2c1e-456d-a571-1ab9e0e5efe2 35 fields · synced May 30, 2026
- EUDAMED 5ea3fcda-7fd1-4b28-8d8c-0c583e1fcce1 61 fields · synced Jun 18, 2026