Lehiso A S

FDA Filings

This page includes the latest FDA filings for Lehiso A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014404688
• FEI Number: 3014404688
• Name: Lehiso A/S
• Owner & Operator: WILLIAM DEMANT HOLDING A/S
• Contact Address: KONGEBAKKEN 9 --; SMORUM DK-NOTA DK-2765 DK
• Official Correspondent:
  • Mette B Dyhrberg
  • 45-20-630183-x
• US Agent:
  • Pat Montello
  • Oticon Inc.
  • 732 5601220 2338
  • 732 5600029
  • pamo@dgs.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: KONGEBAKKEN 9 --; SMORUM Region Hovedstaden, DK-2765 DK
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 05713708000184 Lehiso A/S	Lehiso	2022-08-08
GUDID 05713708000177 Lehiso A/S	Lehiso	2022-08-08
GUDID 05713708000221 Lehiso A/S	Lehiso	2020-05-19
GUDID 05713708000214 Lehiso A/S	Lehiso	2020-05-19
GUDID 05713708000153 Lehiso A/S	Lehiso	2019-03-11
GUDID 05713708000146 Lehiso A/S	Lehiso	2019-03-11
GUDID 05713708000122 Lehiso A/S	Lehiso	2018-09-20
GUDID 05713708000115 Lehiso A/S	Lehiso	2018-09-20
GUDID 05713708000078 Lehiso A/S	Lehiso	2018-03-29
GUDID 05713708000054 Lehiso A/S	Lehiso	2018-03-29
GUDID 05713708000036 Lehiso A/S	Lehiso	2018-03-29
GUDID 05713708000012 Lehiso A/S	Lehiso	2018-03-29
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 9 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 7 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 5 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 3 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 1 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 9 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 7 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 5 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 3 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 1 (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SoundLink2 App (Sonic)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Siya (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ruby (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria2 Pro Tl (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria2 Pro (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria2 (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria Pro (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn S (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn Play (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn 3 (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn 2 (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn 1 (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Nera2 Pro TI (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Nera2 Pro (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Nera2 (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Engage (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Enchant ? family (Sonic)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	EasyControl-A (Bernafon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Captivate? (Sonic)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Alta2 Pro TI (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Alta2 Pro (Oticon)	2015-02-11
PMN K133308 | KLW Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Alta2 (Oticon)	2015-02-11
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	lno Pro (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	lno (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	lnizia 1 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 9 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 7 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 5 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 3 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Zerena 1 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Xceed Play (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Xceed (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	XTREME (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 9 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 7 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 5 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 3 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Viron 1 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Trek (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	TV-A (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	TV Adapter 3.0 (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	TV Adapter (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Streamer XM (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SoundLink2 App (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SoundLink 2 App (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SoundGate 3 (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SoundClip-A (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Sensei Pro (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Sensei (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SUPREMIA 7 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SUPREMIA 3 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SUMO (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SAPHIRA 5 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	SAPHIRA 3 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ruby (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria2 Pro (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria2 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria Pro (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Ria (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	RemoteLink App (Lehiso)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Remote Control (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Remote Care App (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	RC-N (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Phone-Adapter 2.0 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Phone Adapter 2 (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Philips HearLink App (SBO Hearling)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Pep? family (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Oticon ON App (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn3 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn2 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Opn1 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	OPUS 1 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	OASIS nxt (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	OASIS (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Nera2 Pro (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Nera2 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	NEVARA 1 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Leox (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	KINDduro KD10 (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	KINDduro (Lehiso)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	KINDakira KD10 (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Journey family (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	JUNA 9 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	JUNA 7 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Inizia 3 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	HearSuite (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	HearLink000 (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	HearLink 010 (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	HearLink 000 (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	HEARTOO1 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	HEARTOO STUDIO (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Get (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Genie 2 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Genie (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Enchant ? family (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	EduMic (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	EasyControl-A App (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	EXPRESSlink 3 (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	EXPRESSfit? (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	EXPRESSfit PRO? (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Dynamo (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Connnect-line (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	ConnectClip (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Chili (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Cheer ? family (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Celebrate family (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Captivate family (Sonic)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	CROS (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	CARISTA 5 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	CARISTA 3 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	BEFLEX (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	AudioClip (SBO Hearing)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Altena (SBO Hearling)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Alta2 Pro (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Alta 2 (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Acto Pro (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	Acto (Oticon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	ACRIVA 9 (Bernafon)	2012-11-16
OSM Lehiso A/S [WILLIAM DEMANT HOLDING A/S]	ACRIVA 7 (Bernafon)	2012-11-16