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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 5 of 6

Device	Model / Reference	Registries	Class	Status
Pro-Tec III Syringe Shield	007-755	FDA UDI	Class I	Active
Shielded Waste Container	039-110	FDA UDI	Class I	Active
Vial Shield	053-807	FDA UDI	Class I	Active
Pet Shipping System	001-786	FDA UDI	Class I	Active
Clear Lead Barrier	042-585	FDA UDI	Class I	Unknown
Pro-Tec Pet Syringe Shield	007-995	FDA UDI	Class I	Active
Lead Lined	244-112	FDA UDI	Class I	Active
Lead Lined	244-192	FDA UDI	Class I	Active
Surgical C Arm Table	058-847-10	FDA UDI	Class II	Unknown
Bench Top Shield	042-710	FDA UDI	Class I	Active
Atomlab	187-602	FDA UDI	Class I	Active
Pro-Tec III Syringe Shield	007-738	FDA UDI	Class I	Active
Lead Lined	244-151	FDA UDI	Class I	Active
Lead Lined	244-009	FDA UDI	Class I	Active
Pro-Tec Pig	001-281	FDA UDI	Class I	Active
Surgical C Arm Table	058-845	FDA UDI	Class II	Unknown
Xenon Convenience Kits	134-772	FDA UDI	Class II	Active
Pet Dose Drawing Syringe Shield	007-986	FDA UDI	Class I	Active
Pet Gaard Lock, Syringe Shields	007-716	FDA UDI	Class I	Active
Shielded Storage Container	050-205	FDA UDI	Class I	Active
Lead Lined	244-005	FDA UDI	Class I	Active
Xenon Rebreathing System	132-681	FDA UDI	Class II	Active
Pro-Tec IV Syringe Shield	007-670	FDA UDI	Class I	Active
Xenon Rebreathing System	132-784	FDA UDI	Class II	Active
Pro-Tec III Syringe Shield	007-736	FDA UDI	Class I	Active
Lead Lined	244-121	FDA UDI	Class I	Active
Lead Lined	244-136	FDA UDI	Class I	Active
Sharps Container Shield	039-330	FDA UDI	Class I	Unknown
Bar Phantom	243-935	FDA UDI	Class I	Active
Lead Lined	244-150	FDA UDI	Class I	Active
Pet Shipping System	001-787	FDA UDI	Class I	Active
Surgical C Arm Table	056-025	FDA UDI	Class II	Unknown
Pro-Tec IV Syringe Shield	007-675	FDA UDI	Class I	Active
Aerotech I Radioaerosol Administration System	177-095	FDA UDI	Class II	Active
Shipping System	001-692	FDA UDI	Class I	Active
Sharps Container Shield	039-325	FDA UDI	Class I	Active
Z-Pet, Syringe Shield	007-945	FDA UDI	Class I	Active
Pet Gaard Lock, Syringe Shield	007-712	FDA UDI	Class I	Active
Air Cushioned Face Mask	132-695	FDA UDI	Class II	Active
Pet Dose Drawing System	042-466	FDA UDI	Class I	Active
Xenon Rebreathing System	132-781	FDA UDI	Class II	Active
Lead Lined	244-160	FDA UDI	Class I	Active
Pro-Tec II Syringe Shield	007-900	FDA UDI	Class I	Active
Dose Drawing, Syringe Shield	007-691	FDA UDI	Class I	Active
Soda Lime	132-773	FDA UDI	Class II	Active
Pro-Tec Pig	001-282	FDA UDI	Class I	Active
Pet Pig	001-793	FDA UDI	Class I	Active
Micro-Vent	177-107	FDA UDI	Class II	Active
Pro-Tec IV Syringe Shield	007-685	FDA UDI	Class I	Active
3D Imaging C Arm Table	058-825	FDA UDI	Class II	Unknown

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