Terason XY
Ref 10-3363Model Terason XY
Terason XY (10-3363) is a medical device (EU MDR Class IIa; EMDN category ultrasound probes – other) made by Teratech Corporation, registered in EUDAMED on 23 Oct 2023 (Basic UDI-DI 852698007539KB) with CE/MDR certificate 28620253687 valid until 1 Mar 2031, active as of 22 Oct 2026.
Active
CE MDR
Valid until
1 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number28620253687 | Date13 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 852698007539KB
Certificates
- 28620253687 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 13 Aug 2026
- Expires
- 1 Mar 2031
Timeline
- Registered EUDAMED 852698007539KB
- Certificate issued EUDAMED 28620253687
- Certificate expires EUDAMED 28620253687
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- XY Transducer
- Model / reference
- Terason XY, 10-3363
- Primary DI / UDI-DI
- 00852698007539
- Basic UDI-DI
- 852698007539KB
- Direct marketing DI
- 00852698007539
- EMDN code
- Z11040299 Ultrasound probes – other
- Device class
- Class IIa
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000033295
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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