Contour® TS
by Ascensia Diabetes Care Holdings AG 5 variants
Ref 84511161Model CONTS-S-XXXXYY
Contour® TS (84511161) is a Class C device made by Ascensia Diabetes Care Holdings AG, registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI 15016003CONTSSB9Q), active as of 7 Nov 2026.
Active
CE IVDR
Valid until
20 Oct 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number15016003CONTSSB9Q 15016003191302 | Date12 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 15016003CONTSSB9Q
Certificates
- IVDR 785594 Active
Technical documentation EU IVDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 21 Oct 2024
- Expires
- 20 Oct 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Contour TS Blood Glucose Test Strips
- Model / reference
- CONTS-S-XXXXYY, 84511161
- Primary DI / UDI-DI
- 15016003191302
- Basic UDI-DI
- 15016003CONTSSB9Q
- Unit of use DI
- 25016003191309
- EMDN code
- W020106019085 Various diabetes monitoring instruments - consumables
- Device class
- Class C
- EU registration type
- Standard device
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CH-MF-000034124
- Authorised representative
- Ascensia Diabetes Care Italy Srl IT-AR-000025584
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