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Scholten Surgical Instruments, Inc.

United States·US-MF-000034588

Last updated May 27, 2026

Information

Country: United States
Address: 170, Commerce St. , Lodi, United States
Website: www.novatome.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8664523525
PRRC Contact: Jim Van Andel
EUDAMED SRN: US-MF-000034588
FDA FEI Number: —
DUNS Number: 130178346

Catalogue (15)

Device	Model / Reference	Registries	Class	Status
Table Accessories, Operating Room	K852332	FDA 510(k)	Class I	Active
Sys, Angiographic, Single-Or Bi-Plane Radiographic	K852331	FDA 510(k)	Class II	Active
Novatome, Model: Su101-50	K072051	FDA 510(k)	Class II	Active
Retractor, Surgical	K852330	FDA 510(k)	Class I	Active
Temporary Pacemaker Ground Wire	K852119	FDA 510(k)	Class III	Active
Stand, Operating Room	K852329	FDA 510(k)	Class I	Active
Scholten Frame	K900405	FDA 510(k)	Class I	Active
Forceps, Biopsy(non Rigid)	K852120	FDA 510(k)	Class I	Active
Novatome	SU104-100	EUDAMEDFDA UDI	Class III	Active
Novatome	SU104-50	EUDAMEDFDA UDI	Class III	Active
Novatome	SU103-100PC	EUDAMEDFDA UDI	Class III	Active
Novatome	SU103-100	EUDAMEDFDA UDI	Class III	Active
Novatome	SU101-50	EUDAMEDFDA UDI	Class III	Active
Novatome	SU103-50	EUDAMEDFDA UDI	Class III	Active
Novatome	SU102-50	EUDAMEDFDA UDI	Class III	Active

Related Companies

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MedEnvoy Global BV NL

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