NOVO

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1625519	1625519	NOVOSCI CORP.	1	Y	2026-01-01	2021 Airport Road Conroe TX US 77301
2244771	2244771	NOVO NORDISK INC.	1	Y	2026-01-01	800 Scudders Mill Rd Plainsboro NJ US 08536
9681821	3003131673	NOVO NORDISK A/S	1	N	2026-01-01	BRENNUM PARK HILLEROED Hovedstaden DK DK-3400
3005186124	3005186124	Novo Nordisk (China) Pharmaceuticals, Co. Ltd.	1	N	2026-01-01	99 Nanhai Road TEDA Tianjin CN 300457
3008770252	3008770252	NOVO SURGICAL, INC.	1	Y	2026-01-01	407 Plaza Drive Westmont IL US 60559
3009306483	3009306483	NOVOCURE INC	1	Y	2026-01-01	195 Commerce Way Portsmouth NH US 03801
3010457505	3010457505	NOVOCURE GMBH	1	N	2026-01-01	Neuhofstrasse 21 Baar Zug CH 6340
3013043616	3013043616	NOVODIAX, INC.	1	N	2026-01-01	3517 Breakwater Ave Hayward CA US 94545
3014193078	3014193078	NOVOXEL LTD.	1	N	2026-01-01	43 Hamelaha Street Netanya Tel Aviv IL 4250573
3014273644	3014273644	NOVOSOURCE, LLC	1	N	2026-01-01	1000 HAMPTON CTR STE A Morgantown WV US 26505
3014787189	3014787189	NOVOGENIA GMBH	1	N	2026-01-01	Strass 19 Eugendorf Salzburg AT 5301
3030230672	3030230672	NOVODX Corporation	1	N	2026-01-01	110 Front St Ste 300 Jupiter FL US 33477
3030847793	3030847793	NOVOXEL INC.	1	Y	2026-01-01	2627 Ne 203rd St Ste 102 Aventura FL US 33180
3034312680	3034312680	NOVO HEALTH CARE SERVICES LLC	1	Y	2026-01-01	200 Rittenhouse Cir Ste 5 Bristol PA US 19007
3015060245	3015060245	NOVONATE, INC.	1	N	2020-04-25	395 Oyster Point Blvd Ste 501 South San Francisco CA US 94080
3015781810	3015781810	NOVODENT SA	1	N	2020-04-25	Y-PARC Technopole Avenue des Sciences 11 CH-1400 Yverdon-les-Bai Yverdon-les-Bains Vaud CH CH-1400

GUDID Contact Samples

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

Source GUDID	Product	Phone	Email
07290107987462	Connection Cable for Optune Pax - CAD9100	1-855-281-9301	support@novocure.com
07290107987479	Battery for Optune Pax - IBH9200	1-855-281-9301	support@novocure.com
07290107987486	Optune Pax Battery Charger - ICH9100	1-855-281-9301	support@novocure.com
07290107987493	Power Supply for Optune Pax - SPS9200	1-855-281-9301	support@novocure.com
07290107987509	Optune Pax - TFP9200	1-855-281-9301	support@novocure.com

novocure.com

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
140562	1348951220	P250034	Optune Pax	SHC	2026-02-11
161804	1621540556	P250034	Optune Pax	SHC	2026-02-11
161804	1046377550	P230042	Optune Lua	SDA	2024-10-15
140562	1705594435	P230042	Optune Lua	SDA	2024-10-15
161804	1313433202	P100034	NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT	NZK	2011-04-08
140562	1331308272	P100034	NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT	NZK	2011-04-08
22002	1322108875	K990514	MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR	DTP	1999-03-09
123364	1734159381	K974793	ELMED ESU 120 M/M DIGITAL	GEI	1998-03-19
123364	1460443801	K974595	CUSHING BAYONET, INSULATED BIPOLAR FORCEP	HTD	1998-06-24
123364	1674008530	K974382	ACKERMANN SURGICAL INSTRUMENTS	GCJ	1998-04-21
123364	1043848254	K962545	DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE	KCT	1997-03-07
123364	1260886593	K960738	STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)	KCT	1997-05-06
123364	1382149268	K945541	SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE	HKY	1995-05-08
22002	1739771151	K912045	TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST	DXS	1991-10-31
22002	1136109643	K821495	DISPOSABLE BLOOD LINE CONNECTORS	KOC	1982-05-27
22002	1221535812	K820472	WILLIAM HARVEY H-625 ARTERIAL FILTER	DTM	1982-03-15
22002	2031824359	K810532	DISPOSABLE STOPCOCK	DTZ	1981-04-23
22002	1621595846	K802545	CARDIOPLEGIC SETS	DTR	1981-01-16
22002	1753455549	K802542	DISPOSABLE CONNECTORS	KRI	1981-01-16
22002	1698840134	K802541	DISPOSABLE PARALLEL Y CONNECTORS	KRI	1981-01-16
22002	2034282492	K801405	DISPOSABLE PERFUSION CONNECTORS	DTL	1980-06-30
22002	1165302572	K801404	DISPOSABLE PARALLEL Y CONNECTORS	DTL	1980-06-30
22002	1623820540	K801403	DISPOSABLE PERFUSION SET	DWF	1980-06-30
22002	1706079503	K801402	QUICKIE PRIME CARDIOP. BYPASS PERF. INTR	DTL	1980-06-30
22002	1139058154	K801401	CARDIOPULMONARY BYPASS TUBING	DWF	1980-06-30
22002	1885042538	K801400	DISPOSABLE SUCKER SYSTEM	DTS	1980-06-30
22002	1666786646	K801399	CORONARY PERFUSION CONNECTOR PLUG	DTL	1980-06-30
22002	1669060966	K801397	VENA CAVA CANNULAE	DWF	1980-06-30
22002	1349753480	K801396	SAPHENOUS VEIN CANNULAE	DWF	1980-06-30
22002	1515067245	K801395	VASCULAR CLAMP	DXC	1980-06-30
22002	1966099983	K801393	AIR ASPIRATOR NEEDLE	DWS	1980-06-30
22002	1928586540	K801392	DISPOSABLE SUMP SETS	DWF	1980-06-30
22002	1651114094	K770707	TYGON PAC-MONITORING LINES & FLUID ADMIN	FMG	1977-06-03
289379	2013506342	K240512	Tixel i (TXLI0001)	ORZ	2024-11-04
323862	1848975886	K233174	FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream	LCX	2024-02-05
16570	1698140132	K231255	NovoFine® Plus	FMI	2023-08-25
289379	1784453755	K223033	Tixel® 2 System	GEI	2023-06-21
123364	1081921562	K213386	Titan Manufacturing Bipolar Forceps	GEI	2021-10-25
16570	1423395103	K210258	NovoFine	FMI	2021-06-23
16571	1423395103	K210258	NovoFine	FMI	2021-06-23
289379	1339047733	K202988	Tixel System	GEI	2021-02-25
16570	1382197461	K202005	NovoFine Plus 32G Tip x 4 mm	FMI	2020-12-19
16571	1382197461	K202005	NovoFine Plus 32G Tip x 4 mm	FMI	2020-12-19
123364	1253581376	K183438	Geomed Vascular Dilators	DWP	2019-09-03
16570	2008167522	K182387	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)	FMF	2018-12-17
16571	2008167522	K182387	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)	FMF	2018-12-17
186103	2008167522	K182387	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)	FMF	2018-12-17
232972	1462255261	K181266	Implantswiss Dental Implant System, Implantswiss Dental Abutment System	DZE	2018-11-01
123364	1811663279	K181173	ELMED Laparoscopic Instruments and Accessories	GCJ	2019-03-22
16570	1745006875	K173479	NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)	FMI	2018-01-17
16571	1745006875	K173479	NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)	FMI	2018-01-17
123364	1657265402	K163524	Vessel Dilator	DWP	2017-06-29
16570	1643284362	K162602	NovoPen Echo	FMF	2016-10-18
16571	1643284362	K162602	NovoPen Echo	FMF	2016-10-18
186103	1643284362	K162602	NovoPen Echo	FMF	2016-10-18
215621	1426793987	K140701	NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG	OQG	2014-06-27
16570	1189984943	K133738	NOVOFINE PLUS 32G 4 MM	FMI	2014-05-21
16571	1189984943	K133738	NOVOFINE PLUS 32G 4 MM	FMI	2014-05-21
215621	1161105122	K132158	NOVOHIP TOTAL HIP SYSTEM	LPH	2014-02-21
123364	1153244623	K131407	BAHADIR STERILIZATION TRAYS	KCT	2014-08-12
215621	2065094711	K131398	NOVOKNEE TOTAL KNEE SYSTEM	JWH	2013-09-16
215621	1943986271	K123339	TK1 TOTAL KNEE SYSTEM	JWH	2013-04-11
123364	1519066360	K111930	ACKERMANN EUROPCLIP	FZP	2011-11-08
123364	2033280770	K102048	ATRAUMATIC VASCULAR CLAMPS	DXC	2010-11-09
123364	1994561448	K101080	NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX	GEI	2010-06-21
123364	1594858413	K100518	INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054	DWP	2010-08-31
16570	1051318870	K093109	NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')	FMI	2010-06-18
16571	1051318870	K093109	NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')	FMI	2010-06-18
123364	2034519117	K092544	INSTRUMED VASCULAR CLAMPS	DXC	2009-10-26
123364	1364084145	K090131	DS N95 SURGICAL MASKS AND FLAT SURGICAL	MSH	2009-04-27
16570	1016246524	K090111	FLEXPEN NEEDLE	FMI	2010-02-01
16571	1016246524	K090111	FLEXPEN NEEDLE	FMI	2010-02-01
123364	1442139866	K072834	SIBEL SA VASCULAR CLAMP	DXC	2008-01-09
123364	1652471367	K071771	INSTRUMED RETRACTORS	GZT	2007-08-02
123364	1209807482	K060233	TROKAMED GMBH ENDOSCOPES AND ACCESSORIES	GCJ	2006-07-19
123364	1595147643	K051429	CLARIS NON-STICK BIPOLAR FORCEPS	GEI	2005-07-29
16570	1080572543	K050106	NOVOFINE AUTOCOVER 30G X 8MM	FMI	2005-03-30
16571	1080572543	K050106	NOVOFINE AUTOCOVER 30G X 8MM	FMI	2005-03-30
123364	1541171195	K040855	INSTRUMED LAPAROSCOPE AND ACCESSORIES	GEI	2004-04-16
123364	1277750880	K033660	STORZ RANEY SCALP CLIP, MODEL 1-20-004-05	HBO	2004-01-07
123364	1493296095	K010908	MEDICON TITANIUM YASARGIL ANEURYSM CLIPS	HCH	2001-08-01
123364	1930262029	K003500	REBSTOCK YASARGIL ANEURYSM CLIP	HCH	2001-05-30
140562	1103375691	H180002
161804	1737344825	H180002
16570	1012223184
16571	1012223184
123364	1097569173
22002	1207918126
222349	1275644252
123364	1350234504
123364	1713080167
123364	1000011811
123364	1001497188
123364	1002653293
123364	1003616316
123364	1004321261
123364	1005387012
123364	1008228657
123364	1010567623
123364	1015884549
123364	1017882064
123364	1025873328
123364	1027214778
123364	1027901957
123364	1049348762
123364	1052326524
123364	1052729522
123364	1056122629
200583	1057285480
123364	1058897830
123364	1061250667
123364	1064664971
123364	1081831980
123364	1083931853
123364	1084406174
123364	1085409261
123364	1089922592
123364	1100196076
123364	1107088186
123364	1108543707