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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 2 of 10

Device	Model / Reference	Registries	Class	Status
Diversatek Healthcare	1217-10	FDA UDI	Class II	Active
SafeGuide®	1214-02D	FDA UDI	Class II	Active
SafeGuide®	1214-51	FDA UDI	Class II	Active
PriZm	H20-4500	FDA UDI	Class II	Active
WeightRight®	1209-46	FDA UDI	Class II	Active
Viper	1205-12	FDA UDI	Class II	Active
MiVu	MI-REG-01	FDA UDI	Class II	Active
Diversatek Healthcare	GIS-7010	FDA UDI	Class II	Active
WeightRight®	1209-52	FDA UDI	Class II	Active
CleanFreak®	1200-09	FDA UDI	Class I	Active
Diversatek Healthcare	1240-36	FDA UDI	Class I	Active
SafeGuide®	1214-33	FDA UDI	Class II	Active
WeightRight®	1208-44	FDA UDI	Class II	Active
SafeGuide®	1214-48	FDA UDI	Class II	Active
Diversatek Healthcare	1201-51	FDA UDI	Class I	Active
WeightRight®	1209-48	FDA UDI	Class II	Active
CleanFreak®	1200-03	FDA UDI	Class I	Active
SafeGuide® Single	1215-15	FDA UDI	Class II	Active
inSIGHT Ultima	ULT1-S	FDA UDI	Class II	Active
Diversatek Healthcare	1240-40	FDA UDI	Class I	Active
Diversatek Healthcare	1201-68	FDA UDI	Class I	Active
BullDog®	1203-50	FDA UDI	Class II	Active
RePlay	1170-02	FDA UDI	Class II	Active
Diversatek Healthcare	1201-95	FDA UDI	Class I	Active
Diversatek Healthcare	1201-78	FDA UDI	Class I	Active
Diversatek Healthcare	1201-100	FDA UDI	Class I	Active
Viper	1204-12	FDA UDI	Class II	Active
Lasso	1180-15	FDA UDI	Class I	Active
CareGuard®	1197-60	FDA UDI	Class I	Active
WeightRight®	1209-18	FDA UDI	Class II	Active
Diversatek Healthcare	1201-107	FDA UDI	Class I	Active
Diversatek Healthcare	1201-71	FDA UDI	Class I	Active
Diversatek Healthcare	1201-54	FDA UDI	Class I	Active
WeightRight®	1209-28	FDA UDI	Class II	Active
Diversatek Healthcare	1245-20	FDA UDI	Class I	Active
SafeGuide® Single	1215-39	FDA UDI	Class II	Active
Diversatek Healthcare	A86-4100	FDA UDI	Class II	Active
Diversatek Healthcare	SF-1195-70	FDA UDI	Class II	Active
Diversatek Healthcare	1268-03	FDA UDI	Class II	Active
BullDog	1195-22	FDA UDI	Class II	Active
WeightRight®	1209-50	FDA UDI	Class II	Active
SafeGuide® Single	1215-36	FDA UDI	Class II	Active
inSIGHT Ultima	H12R-2000	FDA UDI	Class II	Active
Diversatek Healthcare	1201-106	FDA UDI	Class I	Active
BullDog	1203-72	FDA UDI	Class II	Active
WeightRight®	1208-54	FDA UDI	Class II	Active
Diversatek Healthcare	1201-55	FDA UDI	Class I	Active
Diversatek Healthcare	1245-32	FDA UDI	Class I	Active
Diversatek Healthcare	1201-53	FDA UDI	Class I	Active
Diversatek Healthcare	1201-49	FDA UDI	Class I	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.