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2-Channel-Ring-Applicator CT/MR, 60°, d=35mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref LCT42-3
Identity
- Trade Name
- 2-Channel-Ring-Applicator CT/MR, 60°, d=35mm EUDAMEDFDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- 2-Channel-Ring-Applicator CT/MR EUDAMED
- Model / Reference
- LCT42-3 EUDAMEDLCT42-3#02 FDA UDI
Identifiers
- Catalog Number
- LCT42-3 FDA UDI
- Primary DI / UDI-DI
- 04065983002270 EUDAMED04049223107901 FDA UDI
- Basic UDI-DI
- B-04065983002270 EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
2-Channel-Ring-Applicator CT/MR, 60°, d=35mm by Eckert & Ziegler BEBIG GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eckert & Ziegler BEBIG GmbH
Sources (2)
- FDA UDI 84b3d49d-b156-4e50-a423-d8893dbfeaaa 35 fields · synced Oct 6, 2026
- EUDAMED 67195d60-f2c5-4fb3-aa6d-70ad3ebcb793 61 fields · synced Jul 18, 2026