Identity
- Trade Name
- Transfer Tube, D=3mm, L=1000mm EUDAMEDFDA UDI
- Generic Name
- Remote-afterloading brachytherapy system FDA UDI
- Device Name
- Transfer Tube EUDAMEDThe Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU). FDA UDI
- Model / Reference
- LAF1000 EUDAMED06 FDA UDI
- Description
- The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU). FDA UDI
Identifiers
- Catalog Number
- LAF1000 FDA UDI
- Primary DI / UDI-DI
- 04065983000986 EUDAMEDFDA UDI
- Basic UDI-DI
- 40659830013BCB EUDAMED
- 510(k) Number
- K142986 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Remote-afterloading brachytherapy system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
MR Unsafe FDA UDI
Transfer Tube, D=3mm, L=1000mm by BEBIG Medical GmbH — 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 | 40659830013BCB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BEBIG Medical GmbH
- EUDAMED SRN
- DE-MF-000012644
Sources (2)
- EUDAMED 756915db-7d57-4066-a407-5a4c7ff18ad8 61 fields · synced Jul 30, 2026
- FDA UDI adc92dc3-fc81-4e1d-9c5f-f01a1673b05b 35 fields · synced May 30, 2026