5C1e Transducer 9085
Ref 9085
5C1e Transducer 9085 is a device classified as Class IIa in the EU and Class II in the US made by Bk Medical ApS, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI B-05704916000356) and listed in FDA GUDID since 9 Dec 2016 (UDI-DI 05704916000356), active as of 25 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-05704916000356 05704916000356 | Date15 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05704916000356 | Date9 Dec 2016 | StatusListed |
Official records
- EUDAMED public site B-05704916000356
- AccessGUDID record 05704916000356
Across registries
- EUDAMED Basic UDI-DI B-05704916000356 registered 15 Jul 2026 Active
- FDA GUDID UDI-DI 05704916000356 listed 9 Dec 2016 Listed
Timeline
- Listed FDA GUDID 05704916000356
- Registered EUDAMED B-05704916000356
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- 5C1e EUDAMED5C1e Transducer GUDID
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Device name
- 5C1e Surface transducer
- Model / reference
- 9085
- Primary DI / UDI-DI
- 05704916000356
- Basic UDI-DI
- B-05704916000356
- FDA product code
- ITX
- EMDN code
- Z110402010201 Curvilinear transcutaneous two–dimensional ultrasound probes (convex–array)
- GMDN term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 892.1570
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Denmark
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class II |
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