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Diversatek Healthcare

United States·US-MF-000025177

Last updated September 18, 2026

About

Explore how helping providers achieve GI excellence with innovative diagnostics and training at Diversatek University transforms care.

From the manufacturer's own website. Source

Information

Country: United States
Address: 102 East Keefe Avenue, Milwaukee, WI, United States
Website: diversatekhealthcare.com/
LinkedIn: linkedin.com/company/diversatekhealthcare
Facebook: —
Email: [email protected]
Phone: 1-414-265-7620
PRRC Contact: Laura Boll
EUDAMED SRN: US-MF-000025177
FDA FEI Number: —
DUNS Number: —

Catalogue (466)

Page 4 of 10

Device	Model / Reference	Registries	Class	Status
Diversatek Healthcare	1240-16	FDA UDI	Class I	Active
Diversatek Healthcare	1350-00	FDA UDI	Class II	Active
Diversatek Healthcare	COMP-KIT	FDA UDI	Class II	Active
CleanFreak®	1200-05	FDA UDI	Class I	Active
SafeGuide® Single	1215-21	FDA UDI	Class II	Active
MiVu	MI-SYR-01	FDA UDI	Class II	Active
Diversatek Healthcare	1201-76	FDA UDI	Class I	Active
Diversatek Healthcare	1201-99	FDA UDI	Class I	Active
WeightRight®	1208-22	FDA UDI	Class II	Active
MiVu	MI-CAB-02	FDA UDI	Class II	Active
WeightRight®	1208-56	FDA UDI	Class II	Active
Diversatek Healthcare	SU1102	FDA UDI	Class II	Active
CleanFreak®	1200-07	FDA UDI	Class I	Active
Diversatek Healthcare	CART5R	FDA UDI	Class II	Active
SafeGuide®	1214-02	FDA UDI	Class II	Active
inSIGHT Ultima	ULT1-H-D	FDA UDI	Class II	Active
Diversatek Healthcare	A86-4110-10	FDA UDI	Class II	Active
WeightRight®	1209-16	FDA UDI	Class II	Active
Diversatek Healthcare	1201-86	FDA UDI	Class I	Active
Diversatek Healthcare	1201-112	FDA UDI	Class I	Active
SafeGuide®	1214-03RS	FDA UDI	Class II	Active
InnerVision®	1465-56	FDA UDI	Class I	Active
InnerVision®	1455-56	FDA UDI	Class I	Active
Diversatek Healthcare	SU1103	FDA UDI	Class II	Active
Diversatek Healthcare	1201-94	FDA UDI	Class I	Active
Diversatek Healthcare	1201-50	FDA UDI	Class I	Active
RePlay	1170-01	FDA UDI	Class II	Active
WeightRight®	1208-34	FDA UDI	Class II	Active
InnerVision®	1455-40	FDA UDI	Class I	Active
Zvu®	HRAM-BAL-10	FDA UDI	Class II	Active
Diversatek Healthcare	SU1163	FDA UDI	Class I	Active
Diversatek Healthcare	SU1159	FDA UDI	Class II	Active
WeightRight®	1209-60	FDA UDI	Class II	Active
WeightRight®	1209-32	FDA UDI	Class II	Active
Diversatek Healthcare	EFTV-12V	FDA UDI	Class II	Active
Diversatek Healthcare	SU1161	FDA UDI	Class I	Active
SafeGuide®	1214-27	FDA UDI	Class II	Active
GIJaw	1190-02	FDA UDI	Class I	Active
SafeGuide® Single	1215-27	FDA UDI	Class II	Active
Diversatek Healthcare	SU1101	FDA UDI	Class II	Active
inSIGHT Ultima	ULT1-S-IA	FDA UDI	Class II	Active
Diversatek Healthcare	1201-67	FDA UDI	Class I	Active
Diversatek Healthcare	S98-1925-5P1	FDA UDI	Class II	Active
WeightRight®	1208-24	FDA UDI	Class II	Active
Diversatek Healthcare	NU1060	FDA UDI	Class II	Active
BullDog®	1203-20	FDA UDI	Class II	Active
InnerVision®	1455-50	FDA UDI	Class I	Active
Diversatek Healthcare	1201-77	FDA UDI	Class I	Active
Zvu®	HRAM-200	FDA UDI	Class II	Active
WeightRight®	1209-10	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 18, 2026	Z-1941-2026	—	open, classified	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Mar 18, 2026	Z-1940-2026	—	open, classified	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Mar 18, 2026	Z-1938-2026	—	open, classified	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Mar 18, 2026	Z-1939-2026	—	open, classified	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Jun 4, 2025	Z-2324-2025	—	open, classified	Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
Jul 25, 2023	Z-2521-2023	—	open, classified	GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Oct 29, 2021	Z-1771-2022	—	terminated	M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.