EasyT
Part of a family of 47 devices: see the family page
Ref 450-025-134
EasyT (450-025-134) is a Class III device made by SIS Medical AG, registered in EUDAMED on 26 Mar 2025 (Basic UDI-DI 764014257NIC_ETEM) with CE/MDR certificate 44911221715 valid until 27 Feb 2030, active as of 23 Oct 2026.
Active
CE MDR
Valid until
27 Feb 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number44911221715 | Date22 May 2026 | StatusActive |
Official records
- EUDAMED public site 764014257NIC_ETEM
Certificates
- 44911221715 Active
Quality management system EU MDR
- Certifier
- TÜV NORD CERT GmbH 0044
- Issued
- 22 May 2026
- Expires
- 27 Feb 2030
- Reason
- Other
- 44912221715 Active
Technical documentation EU MDR
- Certifier
- TÜV NORD CERT GmbH 0044
- Issued
- 22 May 2026
- Expires
- 27 Feb 2030
- Reason
- Mnf ar change
Timeline
- Registered EUDAMED 764014257NIC_ETEM
- Certificate issued EUDAMED 44911221715
- Certificate issued EUDAMED 44912221715
- Certificate expires EUDAMED 44911221715
- Certificate expires EUDAMED 44912221715
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 450-025-134
- Primary DI / UDI-DI
- 07640142573937
- Basic UDI-DI
- 764014257NIC_ETEM
- Direct marketing DI
- 07640142573937
- EMDN code
- C010401020101 Ptca balloon dilation catheters
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000015821
- Authorised representative
- EUMEDIQ GmbH DE-AR-000007809
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