Scholten Surgical Instruments, Inc.

Certificate 25 0466 TD/NB

Issued

Valid until: Dec 1, 2030

Certificate 25 0466 TD/NB is a valid Technical documentation issued to Scholten Surgical Instruments, Inc. and registered in EUDAMED. Valid until December 1, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 25 0466 TD/NB
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 102325 0466 TD/NB

Validity

Issued: Dec 2, 2025
Valid from: Dec 2, 2025
Valid until: Dec 1, 2030

Manufacturer

Manufacturer: Scholten Surgical Instruments, Inc.
Manufacturer SRN: US-MF-000034588
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 1023
Notified body country: Czechia

Covered devices

Novatome Endomyocardial Biopsy ForcepsClass III
08662150000NOVATOMEWK

Linked SSCPs

SSCP OTH0076

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III1

1 scope

Novatome Endomyocardial Biopsy Forceps
Class III
08662150000NOVATOMEWK

Documents

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