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Biodex Medical Systems

United States·US-MF-000028834

Last updated June 8, 2026

Information

Country: United States
Address: 49, Natcon Drive, Shirley, United States
Website: simbex.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 6034482367
PRRC Contact: Amaris Ajamil
EUDAMED SRN: US-MF-000028834
FDA FEI Number: —
DUNS Number: —

Catalogue (271)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Lead Lined	244-162	FDA UDI	Class I	Active
Lead Lined	244-200	FDA UDI	Class I	Active
Ultrasound Table	058-727	FDA UDI	Class I	Unknown
Lead Lined	244-131	FDA UDI	Class I	Active
Intego	001-708	FDA UDI	Class I	Active
Flood Phantom	243-054	FDA UDI	Class I	Active
Vial Shield	053-611	FDA UDI	Class I	Active
Pet Shipping System	001-724	FDA UDI	Class I	Active
Shipping System	001-894	FDA UDI	Class I	Active
High Density Lead Glass, Syringe Shield	007-612	FDA UDI	Class I	Active
Lead Lined	244-120	FDA UDI	Class I	Active
Lead Lined	244-206	FDA UDI	Class I	Active
Xenon Rebreathing System	132-770	FDA UDI	Class II	Active
Vasc Pro Table	058-733	FDA UDI	Class I	Unknown
Mobility Assist	950-570	FDA UDI	Class I	Active
L-Block Shield	042-413	FDA UDI	Class I	Active
Vial Shield	001-236	FDA UDI	Class I	Active
Ultra Pro Table	058-720	FDA UDI	Class I	Unknown
Lead Lined	244-190	FDA UDI	Class I	Active
Pet Gaard Lock, Syringe Shield	007-713	FDA UDI	Class I	Active
Sharps Container Shield	039-412	FDA UDI	Class I	Active
Lead Lined	244-110	FDA UDI	Class I	Active
Intego	001-723	FDA UDI	Class I	Active
Echo Pro Table	058-700	FDA UDI	Class I	Unknown
Shipping System	001-822	FDA UDI	Class I	Active
Atomlab 500 Plus	086-332	FDA UDI	Class II	Active
Pet Dose Drawing Sytem	042-467	FDA UDI	Class I	Active
Pro-Tec Pet Syringe Shield	007-985	FDA UDI	Class I	Active
MRI Stretcher Fowler Back	240-110	FDA UDI	Class II	Unknown
L-Block Shield	042-433	FDA UDI	Class I	Active
Xenon Rebreathing System	132-793	FDA UDI	Class II	Active
L-Block Shield	042-449	FDA UDI	Class I	Active
L-Block Shield	042-419	FDA UDI	Class I	Active
Shielded Waste Container	039-106	FDA UDI	Class I	Active
Biosway	950-460	FDA UDI	Class I	Active
Atomlab	187-600	FDA UDI	Class I	Active
Zevalin	001-788	FDA UDI	Class I	Active
Balance Sd	950-440	FDA UDI	Class I	Active
Atomlab Wipe Test Counter	086-331	FDA UDI	Class II	Active
Pet Gaard Lock, Syringe Shield	007-711	FDA UDI	Class I	Active
Sharps Container Shield	039-326	FDA UDI	Class I	Active
MJS System 3 Upgrade	850-820	FDA UDI	Class II	Unknown
Drierite	132-772	FDA UDI	Class II	Active
Pro-Tec Shipping System	001-754	FDA UDI	Class I	Active
Surgical C Arm Table	058-870-10	FDA UDI	Class II	Unknown
Bar Phantom	243-986	FDA UDI	Class I	Active
Lead Lined	244-171	FDA UDI	Class I	Active
Surgical C Arm Table	058-846	FDA UDI	Class II	Unknown
Venti-Scan	177-091	FDA UDI	Class II	Active
Sharps Container Shield	039-335	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

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
Aug 16, 2021	Z-2581-2021	—	terminated	When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
Aug 16, 2021	Z-2580-2021	—	terminated	When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration