Identity
- Trade Name
- GL8LRS EUDAMED
- Device Name
- Broadsound GL8LRS Diagnostic Ultrasound Transducer Assembly EUDAMED
- Model / Reference
- GL8LRS EUDAMED795GL8LRSU50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719890772688 EUDAMED
- Basic UDI-DI
- B-04719890772688 EUDAMED
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Extracorporeal ultrasound imaging transducer, hand-held
Gl8lrs by Broadsound Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719890772688 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Broadsound Corporation
- EUDAMED SRN
- TW-MF-000018523
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 70d1721a-1a32-40c7-82a7-007b305d1a7d 61 fields · synced Jul 14, 2026