Bion Enterprises, Ltd.
Active in EUDAMEDUnited Statesfrom EUDAMED address EUDAMED FDA SRN US-MF-000060006 FEI 1419968
- Devices
- 106
- Registrations
- EUDAMEDFDA
- FDA recalls
- 3
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 106 devicesShowing 1-50 of 106
Company details
- EUDAMED SRN
- US-MF-000060006
- FDA FEI number
- 1419968
- DUNS number
- 024824641
- EUDAMED status
- Active
- EUDAMED registered name
- Bion Enterprises, Ltd.
- Address
- 455 State St Ste 100, DES PLAINES, IL, 60016
- [email protected]
- Phone
- 847-544-5044
- PRRC contact
- Nadine Shabat
FDA recalls
2013
- 23 Jan 2013 Z-1477-2013 Class III Terminated Affected products have a labeled expiration date of one year too long.
Full distribution text
- 23 Jan 2013 Z-1478-2013 Class III Terminated Affected products have a labeled expiration date of one year too long.
Full distribution text
- 23 Jan 2013 Z-1479-2013 Class III Terminated Affected products have a labeled expiration date of one year too long.
Full distribution text
- 23 Jan 2013 Z-1477-2013 Class III Terminated Affected products have a labeled expiration date of one year too long.
Frequently asked questions
How many devices does Bion Enterprises, Ltd. have in the registry?
The registry currently lists 106 devices for Bion Enterprises, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bion Enterprises, Ltd.'s devices?
Among its 50 most recently registered devices, Bion Enterprises, Ltd. has devices listed in FDA GUDID (50 devices).
What risk classes do Bion Enterprises, Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bion Enterprises, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bion Enterprises, Ltd.?
FDA recall records list 3 recalls initiated by Bion Enterprises, Ltd., the most recent initiated on 2013-01-23. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bion Enterprises, Ltd. in the registry?
The most recently registered devices listed for Bion Enterprises, Ltd. include Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System MP-1206, Enterovirus Panel Antigen Control Slide, 4 wells QEP-6604, Parainfluenza 2 Virus Antigen Substrate, 12 wells, For IFA Test System P2-8112 and Measles IgG Control MEG-6020.