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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Novatome

UDI-DI 00866215000002Basic UDI-DI 08662150000NOVATOMEWK

Class III · MDR · Scholten Surgical Instruments, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

25 0466 TD/NB

EU technical documentation assessment · valid

Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 (1023)

Valid from 2025-12-02 · Expiry 2030-12-01

Scope not stated in certificate data.

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

Manufacturer

Scholten Surgical Instruments, Inc.

SRN US-MF-000034588

US · Lodi

manufacturer

Authorised representative: MedEnvoy Global BV (NL-AR-000024028)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/novatome-0002 · UDI page: /udi/00866215000002

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