FDA.reportPublic FDA data

HOSPITECH MANUFACTURING SERVICES SDN BHD

Matched from indexed company URL: HOSPITEC, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035282283003528228HOSPITECH MANUFACTURING SERVICES SDN BHD1N2026-01-01Sub Lot 1, Lot 6536, Batu 6, Jalan Bukit Kemuning, Seksyen 34 Shah Alam Selangor MY 40460
30080092983008009298Hospitec USA1N2026-01-013730 Wheeler Ave Fort Smith AR US 72901

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290015409124AnapnoGuard™ Endotracheal Tube 7.0mm - The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.+97239191648info@cuffill.com
07290015409155AnapnoGuard™ Endotracheal Tube 7.5mm - The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.+97239191648info@cuffill.com
07290015409162AnapnoGuard™ Endotracheal Tube 8.0mm - The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.+97239191648info@cuffill.com
17290015409107AG100s control unit - AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.+97239191648info@cuffill.com
17290015409114AG Connection KIT - AG Connection KIT is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.+97239191648yoel@hospitech.co.il
27290015409128AnapnoGuard™ Endotracheal Tube 7.0mm - The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.+97239191648info@cuffill.com
27290015409159AnapnoGuard™ Endotracheal Tube 7.5mm - The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.+97239191648info@cuffill.com
27290015409166AnapnoGuard™ Endotracheal Tube 8.0mm - The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.+97239191648info@cuffill.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1086971017165013K954500HOSPITEC MEDI-BUTLERFMI1996-01-18
3478591038820063
3478591049623987
3478591087927570
3478591156451128
3478591183967719
3478591261103647
3478591368412217
3478591374819628
3478591418002070
3478591422660545
3478591435513124
3478591465552868
3478591574444668
3478591598579773
3478591628853028
3478591659200352
3478591673440062
3478591690818824
3478591749510334
3478591760294545
3478591770228851
3478591851458369
3478591871408074
3478591886613337
3478591932320893
3478591941218421
3478591963677399
3478592014741756
3478592025274754
3478592051500640

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI11996-01-18

PMN#

GUDID#