E10C4 Transducer 9019
Ref 9019
E10C4 Transducer 9019 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 17 Jul 2026 (Basic UDI-DI B-05704916000073) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 05704916000073), active as of 23 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-05704916000073 05704916000073 | Date17 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05704916000073 | Date17 Sep 2016 | StatusListed |
Official records
- EUDAMED public site B-05704916000073
- AccessGUDID record 05704916000073
Across registries
- EUDAMED Basic UDI-DI B-05704916000073 registered 17 Jul 2026 Active
- FDA GUDID UDI-DI 05704916000073 listed 17 Sep 2016 Listed
Timeline
- Listed FDA GUDID 05704916000073
- Registered EUDAMED B-05704916000073
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- E10C4 EUDAMEDE10C4 Transducer GUDID
- Generic name
- Rectal/vaginal ultrasound imaging transducer
- Device name
- E10C4 Endocavity transducer
- Model / reference
- 9019
- Primary DI / UDI-DI
- 05704916000073
- Basic UDI-DI
- B-05704916000073
- FDA product code
- ITX
- EMDN code
- Z1104020201 Endocavitary ultrasound probes, two–dimensional
- GMDN term
- Rectal/vaginal ultrasound imaging transducer
- 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 |
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 05704916000073: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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