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Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Hypotonic Solution 2

UDI-DI 08051380350119Basic UDI-DI 805138035HypotonicSolVA

Class III · MDR · Quince Therapeutics S.p.A.

Identification
Model
Hypotonic Solution
EMDN
B99
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 00263-B

EU technical documentation assessment · valid

Notified body: KIWA CERMET ITALIA S.P.A. (0476)

Valid from 2026-09-17 · Expiry 2031-09-16

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

MDR 00263-A

EU quality management system · valid

Notified body: KIWA CERMET ITALIA S.P.A. (0476)

Valid from 2026-09-17 · Expiry 2031-09-16

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Quince Therapeutics S.p.A.

SRN IT-MF-000010896

IT · Bresso

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hypotonic-solution-2-0119 · UDI page: /udi/08051380350119

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