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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Scholten Surgical Instruments, Inc. — Manufacturer in United States

MD Atlas update: Aug 5, 2026

SS

Scholten Surgical Instruments, Inc.

United States

All roles followed

Views by role

Sources: EUDAMED

Legal information of SSI

Legal name: Scholten Surgical Instruments, Inc.
EU VAT number: Not applicable
SRN (displayed role): US-MF-000034588
EUDAMED status: Active· registered in 2023
Registered office: Commerce St., 170 95240 Lodi, United States

Contact details for SSI

Phone: 8664523525
Email: nmonce@novatome.com
Website: www.novatome.com
Address: 170, COMMERCE ST. SUITE #101 95240 LODI UNITED STATES

Data export

Export the 7 devices of SSI

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SRNUS-MF-000034588

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Medical device manufacturers in EUDAMED

Competent authority for SSI

Ministerie van Volksgezondheid, Welzijn en Sport
NetherlandsContact the authority →

Executives & regulatory representatives of SSI

2 contacts identified

VAN ANDEL Jim
PRRC
View profile →
VAN ANDEL Jim
Regulatory compliance, ensuring the conformity of the device, post market surveillance, technical documentation, and reporting obligations.
Hidden

Related documents of SSI

Technical documentation

Certificate 25 0466 TD/NB

Issued

Manufacturer

Scholten Surgical Instruments, Inc.

Notified body

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

1023

Version

1

Valid from

12/2/2025

Valid until

12/1/2030

Quality management system

Certificate 25 0465 QR/NB

Issued

Manufacturer

Scholten Surgical Instruments, Inc.

Notified body

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

1023

Version

1

Valid from

12/2/2025

Valid until

12/1/2030

Certificates of SSI

Cartography of SSI

Authorised representativeNotified bodiesPeople

— 2 certificates — SSI
— represents — SSI
— SSI

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

MedEnvoy Global BV

7Total Devices

1Basic UDI-DIs

2Certificates2 valid · 0 expiring < 12 months

5CountriesEU/EEA placements

Market presence of SSI

Devices placed in 5 countries

Austria7
Belgium7
Denmark7
Italy7
Netherlands7

Risk categories of SSI

Catalog of SSI

7 devices · 1 family

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Novatome Endomyocardial Biopsy Forceps7 versions

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