Origio A S

FDA Filings

This page includes the latest FDA filings for Origio 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: 3004048494
• FEI Number: 3004048494
• Name: ORIGIO A/S
• Owner & Operator: ORIGIO A/S
• Contact Address: Knardrupvej 2 --; Malov DK-NOTA 2760 DK
• US Agent:
  • Claudia Navarro
  • Cooper Surgical Inc.
  • 475 2399568 4870
  • Claudia.Navarro@coopersurgical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Knardrupvej 2 ; Malov, 2760 DK
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 60888937027138 Origio A/S	SAGE Vitrification Warming Kit XL	2022-12-01
GUDID 00888937833027 Origio A/S	SynVitro Hyadase	2021-01-26
PMN K200815 ORIGIO A/s	VitriGuard	2020-06-25
GUDID 00888937819342 Origio A/S	CSC Freezing Medium	2019-09-12
GUDID 00888937801491 Origio A/S	EmbryoAssist	2019-08-29
GUDID 00888937833072 Origio A/S	SAGE 1-Step	2019-03-11
GUDID 00888937833058 Origio A/S	SAGE 1-Step	2019-03-11
GUDID 20888937972799 Origio A/S	Transem Stylet 19 cm = 24 cm ET	2019-01-23
GUDID 20888937972379 Origio A/S	EchoGen Spherical O	2019-01-23
GUDID 20888937972362 Origio A/S	Transem Spherical O 24 cm	2019-01-23
GUDID 20888937972355 Origio A/S	EchoGen Spherical	2019-01-23
GUDID 20888937972348 Origio A/S	Transem Spherical	2019-01-23
PMN K180740 | MQK ORIGIO A/S	ORIGIO A/S	2018-11-07
GUDID 20888937021497 Origio A/S	VitriGuard	2018-11-05
GUDID 20888937021480 Origio A/S	VitriGuard	2018-11-05
GUDID 20888937021473 Origio A/S	VitriGuard	2018-11-05
GUDID 20888937021466 Origio A/S	VitriGuard	2018-11-05
GUDID 20888937020438 Origio A/S	VitriGuard	2018-11-05
GUDID 20888937020421 Origio A/S	VitriGuard	2018-11-05
GUDID 20888937020414 Origio A/S	VitriGuard	2018-11-05
GUDID 20888937020391 Origio A/S	VitriGuard	2018-11-05
GUDID 00888937835489 Origio A/S	Origio Handling 8311	2018-10-24
GUDID 00888937835472 Origio A/S	Origio Handling 8311	2018-10-24
GUDID 00888937835465 Origio A/S	Origio Handling 8310	2018-10-24
GUDID 00888937835458 Origio A/S	Origio Handling 8310	2018-10-24
GUDID 20888937014826 Origio A/S	VitriGuard	2018-10-04
GUDID 20888937020513 Origio A/S	VitriGuard	2018-10-03
GUDID 20888937020506 Origio A/S	VitriGuard	2018-10-03
GUDID 20888937020490 Origio A/S	VitriGuard	2018-10-03
GUDID 20888937020483 Origio A/S	VitriGuard	2018-10-03
GUDID 20888937014819 Origio A/S	VitriGuard	2018-10-03
GUDID 20888937014802 Origio A/S	VitriGuard	2018-10-03
GUDID 20888937014796 Origio A/S	VitriGuard	2018-10-03
GUDID 60888937830486 Origio A/S	SAGE Vitrification Warming Kit	2018-09-25
GUDID 60888937830448 Origio A/S	SAGE Vitrification Kit	2018-09-25
GUDID 60888937819597 Origio A/S	Vitrification Warming Kit	2018-09-25
GUDID 60888937819511 Origio A/S	Vitrification Kit	2018-09-25
PMN K173731 | MQL ORIGIO A/S	SAGE Vitrification Kit, SAGE Vitrification Warming Kit	2018-08-31
GUDID 60888937816886 Origio A/S	ORIGIO Gradient 40/80	2018-07-06
GUDID 60888937816879 Origio A/S	ORIGIO Gradient 40/80	2018-07-06
GUDID 60888937816862 Origio A/S	ORIGIO Gradient 40/80	2018-07-06
GUDID 60888937816268 Origio A/S	Embryo Thawing Pack	2018-07-06
GUDID 60888937816244 Origio A/S	BlastThaw	2018-07-06
GUDID 60888937816220 Origio A/S	BlastFreeze	2018-07-06
GUDID 60888937816206 Origio A/S	Embryo Freezing Pack	2018-07-06
GUDID 60888937804128 Origio A/S	IVM System	2018-07-06
GUDID 60888937801783 Origio A/S	MC Vitrification Warming	2018-07-06
GUDID 60888937801745 Origio A/S	MC Vitrification Cooling	2018-07-06
GUDID 60888937801301 Origio A/S	Embryo Thawing Pack	2018-07-06
GUDID 60888937801134 Origio A/S	SupraSperm System	2018-07-06
GUDID 60888937801103 Origio A/S	SupraSperm System	2018-07-06
GUDID 60888937800601 Origio A/S	BlastThaw	2018-07-06
GUDID 60888937800571 Origio A/S	BlastFreeze	2018-07-06
GUDID 60888937800182 Origio A/S	Embryo Freezing Pack	2018-07-06
GUDID 20888937829390 Origio A/S	Sperm Preparation Medium	2018-07-06
GUDID 20888937817984 Origio A/S	ICSI Cumulase	2018-07-06
GUDID 20888937817960 Origio A/S	SynVitro Hyadase	2018-07-06
GUDID 20888937817595 Origio A/S	SpermSlow	2018-07-06
GUDID 20888937817557 Origio A/S	PVP Clinical Grade	2018-07-06
GUDID 20888937817519 Origio A/S	Flushing Medium	2018-07-06
GUDID 20888937817403 Origio A/S	Sperm Preparation Medium	2018-07-06
GUDID 20888937817373 Origio A/S	Acidified Tyrodes Solution	2018-07-06
GUDID 20888937817199 Origio A/S	Universal IVF Medium	2018-07-06
GUDID 20888937817151 Origio A/S	Universal IVF Medium	2018-07-06
GUDID 20888937816901 Origio A/S	ORIGIO Sperm Wash	2018-07-06
GUDID 20888937816840 Origio A/S	ORIGIO Gradient 100	2018-07-06
GUDID 20888937801198 Origio A/S	SupraSperm	2018-07-06
GUDID 20888937800856 Origio A/S	Sperm Preparation Medium	2018-07-06
GUDID 20888937800306 Origio A/S	Universal IVF Medium	2018-07-06
GUDID 20888937800214 Origio A/S	Universal IVF Medium	2018-07-06
GUDID 20888937800085 Origio A/S	Liquid Paraffin	2018-07-06
GUDID 00888937832082 Origio A/S	ORIGIO Sequential Blast	2018-07-06
GUDID 00888937832051 Origio A/S	ORIGIO Sequential Blast	2018-07-06
GUDID 00888937816891 Origio A/S	ORIGIO Sperm Wash	2018-07-06
GUDID 00888937816853 Origio A/S	ORIGIO Gradient 90	2018-07-06
GUDID 00888937816822 Origio A/S	ORIGIO Gradient 100	2018-07-06
GUDID 00888937804331 Origio A/S	ORIGIO Sequential Blast	2018-07-06
GUDID 00888937804317 Origio A/S	ORIGIO Sequential Blast	2018-07-06
GUDID 00888937804294 Origio A/S	ORIGIO Sequential Cleav	2018-07-06
GUDID 00888937804270 Origio A/S	ORIGIO Sequential Cleav	2018-07-06
GUDID 00888937804256 Origio A/S	ORIGIO Sequential Cleav	2018-07-06
GUDID 00888937804232 Origio A/S	ORIGIO Sequential Cleav	2018-07-06
GUDID 00888937804218 Origio A/S	ORIGIO Sequential Fert	2018-07-06
GUDID 00888937804195 Origio A/S	ORIGIO Sequential Fert	2018-07-06
GUDID 00888937804171 Origio A/S	ORIGIO Sequential Fert	2018-07-06
GUDID 00888937804157 Origio A/S	ORIGIO Sequential Fert	2018-07-06
GUDID 00888937803402 Origio A/S	SAGE 1-Step	2018-07-06
GUDID 00888937803389 Origio A/S	SAGE 1-Step	2018-07-06
GUDID 00888937803365 Origio A/S	SAGE 1-Step	2018-07-06
GUDID 00888937803341 Origio A/S	SAGE 1-Step	2018-07-06
GUDID 00888937801903 Origio A/S	SynVitro Flush	2018-07-06
GUDID 00888937801477 Origio A/S	BlastGen	2018-07-06
GUDID 00888937801453 Origio A/S	EmbryoGen	2018-07-06
GUDID 00888937801415 Origio A/S	UTM	2018-07-06
GUDID 00888937801224 Origio A/S	SupraSperm	2018-07-06
GUDID 00888937801026 Origio A/S	PVP Medium	2018-07-06
GUDID 00888937800968 Origio A/S	Flushing Medium	2018-07-06
GUDID 00888937800791 Origio A/S	Sperm Preparation Medium	2018-07-06
GUDID 00888937800708 Origio A/S	Sperm Preparation Medium	2018-07-06
GUDID 00888937800678 Origio A/S	Sperm Freezing Medium	2018-07-06
GUDID 00888937800654 Origio A/S	Biopsy Medium	2018-07-06
GUDID 00888937800555 Origio A/S	UTM	2018-07-06
GUDID 00888937800111 Origio A/S	Liquid Paraffin	2018-07-06
PMN K180740 ORIGIO A/s	VitriGuard	2018-05-04
PMN K173624 | MQL ORIGIO A/S	ORIGIO Handling	2018-03-15
PMN K173624 Origio A/s	ORIGIO® Handling™ Without Phenol Red (Cat. No. 8310), ORIGIO® Handling™ With Phenol Red (Cat. No. 8311)	2018-03-02
PMN K172197 | MQL ORIGIO A/S	SAGE 1-Step GM-CSF with SPS	2017-11-03
PMN K172197 | MQL ORIGIO A/S	SAGE 1-Step GM-CSF with HSA	2017-11-03
PMN K172197 ORIGIO A/s	SAGE 1-Step GM-CSF With HSA, SAGE 1-Step GM-CSF With SPS	2017-10-13
PMN K161547 | MQF ORIGIO A/S	Transem Stylet	2017-06-14
PMN K161547 | MQF ORIGIO A/S	Transem Spherical	2017-06-14
PMN K161547 | MQF ORIGIO A/S	Transem Angled	2017-06-14
PMN K161547 | MQF ORIGIO A/S	EchoGen Spherical	2017-06-14
PMN K161547 | MQF ORIGIO A/S	EchoGen Angled	2017-06-14
PMN K170560 | MQL ORIGIO A/S	SAGE Vitrification Warming Kit	2017-04-05
PMN K170560 | MQL ORIGIO A/S	SAGE Vitrification Kit	2017-04-05
PMN K162833 | MQK ORIGIO A/S	VitriGuard	2017-03-10
PMN K161547 ORIGIO A/S	Transem And EchoGen Embryo Transfer Catheters	2017-03-09
PMN K162833 ORIGIO A/S	VitriGuard	2017-02-16
PMN K153267 | MQL ORIGIO A/S	Origio Sperm Wash	2016-12-16
PMN K153267 | MQL ORIGIO A/S	Origio Gradient 90	2016-12-16
PMN K153267 | MQL ORIGIO A/S	Origio Gradient 40/80	2016-12-16
PMN K153267 | MQL ORIGIO A/S	Origio Gradient 100	2016-12-16
PMN K153267 ORIGIO A/S	ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash	2016-07-22
PMN K152932 | MQL ORIGIO A/S	BlastGen	2016-03-10
PMN K152932 ORIGIO A/S	BlastGen	2016-02-29
PMN K991395 | MQL ORIGIO A/S	QA HTF Medium w/HEPES	2015-05-20
PMN K991393 | MQL ORIGIO A/S	Hyaluronidase 80 U/ml	2015-05-20
PMN K991392 | MQL ORIGIO A/S	Human Serum Albumin	2015-05-20
PMN K991381 | MQL ORIGIO A/S	PureCeption, Lower & Upper Phase	2015-05-20
PMN K991380 | MQL ORIGIO A/S	Oil for tissue culture	2015-05-20
PMN K991379 | MQL ORIGIO A/S	Quinn's Sperm Washing Medium	2015-05-20
PMN K991378 | MQL ORIGIO A/S	Phosphate Buffered Saline (PBS)	2015-05-20
PMN K053646 | MQL ORIGIO A/S	In Vitro Maturation Media (IVM)	2015-05-20
PMN K003734 | MQL ORIGIO A/S	QA Serum Protein Substitute	2015-05-20
PMN K002836 | MQL ORIGIO A/S	QA Protein + Fert. Medium	2015-05-20
PMN K002836 | MQL ORIGIO A/S	QA Protein + Cleavage Medium	2015-05-20
PMN K002836 | MQL ORIGIO A/S	QA Protein + Blastocyst Medium	2015-05-20
PMN K002836 | MQL ORIGIO A/S	QA Medium w/HEPES	2015-05-20
PMN K002836 | MQL ORIGIO A/S	QA Fertilization Medium	2015-05-20
PMN K002836 | MQL ORIGIO A/S	QA Cleavage Medium	2015-05-20
PMN K002836 | MQL ORIGIO A/S	QA Blastocyst Medium	2015-05-20
PMN K991391 | MQL ORIGIO A/S	PVP 7%	2015-05-19
PMN K991390 | MQL ORIGIO A/S	QA Thaw Kit	2015-05-19
PMN K991390 | MQL ORIGIO A/S	QA Sperm Freeze Kit	2015-05-19
PMN K991390 | MQL ORIGIO A/S	QA Embryo Freeze Kit	2015-05-19
PMN K991390 | MQL ORIGIO A/S	QA Blastocyst Freeze Kit	2015-05-19
PMN K073522 | MQL ORIGIO A/S	Vitrification kit &	2015-05-19
PMN K073522 | MQL ORIGIO A/S	Vitrification Warming Kit	2015-05-19
PMN K140317 | MQL ORIGIO A/S	EmbryoGen?	2014-07-22
PMN K140317 ORIGIO A/S	EMBRYOGEN	2014-06-16
PMN K133912 | MQL ORIGIO A/S	ORIGIO? Sequential Fert?	2014-05-15
PMN K133912 | MQL ORIGIO A/S	ORIGIO? Sequential Fert? with phenol red	2014-05-15
PMN K133912 | MQL ORIGIO A/S	ORIGIO? Sequential Cleav?	2014-05-15
PMN K133912 | MQL ORIGIO A/S	ORIGIO? Sequential Cleav? with phenol red	2014-05-15
PMN K133387 | MQL ORIGIO A/S	ORIGIO? Sequential Blast?	2014-05-15
PMN K133387 | MQL ORIGIO A/S	ORIGIO? Sequential Blast? with phenol red	2014-05-15
PMN K133912 ORIGIO A/S	ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO	2014-05-14
PMN K133707 | MQL ORIGIO A/S	SAGE 1-Step? supplemented with Serum Protein Supplement	2014-04-30
PMN K133707 | MQL ORIGIO A/S	SAGE 1-Step? supplemented with Human Serum Albumin	2014-04-30
PMN K133387 ORIGIO A/S	ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED	2014-04-29
PMN K133707 ORIGIO A/S	SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS	2014-04-16
PMN K120136 ORIGIO A/S	EMBRYOGEN	2012-09-26
PMN K100367 | MQL ORIGIO A/S	VITRIFICATION COOLING/WARMING	2010-12-06
PMN K100367 | MQL ORIGIO A/S	VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229	2010-12-06
PMN K100367 | MQL ORIGIO A/S	MEDICULT VITRIFICATION COOLING/WARMING	2010-12-06
PMN K100367 ORIGIO A/S	MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229	2010-08-27
PMN K991470 | MQL ORIGIO A/S	Acidified Tyrodes	2010-02-16
PMN K991335 | MQL ORIGIO A/S	Medi-Cult Freezing Pack and Thawing Pack	2010-02-16
PMN K991332 | MQL ORIGIO A/S	Sperm Preparation Medium	2010-02-16
PMN K991330 | MQL ORIGIO A/S	Liquid Paraffin	2010-02-16
PMN K991327 | MQL ORIGIO A/S	Flushing Medium	2010-02-16
PMN K991279 | MQL ORIGIO A/S	Universal IVF	2010-02-16
PMN K030490 | MQL ORIGIO A/S	ISM1, ISM2, UTM	2010-02-16
PMN K991333 | MQL ORIGIO A/S	Sperm Freeze Medium	2010-02-11
PMN K991329 | MQL ORIGIO A/S	PVP Medium	2010-02-11
PMN K991329 | MQL ORIGIO A/S	PVP Clinical Grade	2010-02-11
PMN K081639 | MQL ORIGIO A/S	ICSI Cumulase	2008-09-23
PMN K061145 | MQL ORIGIO A/S	SpermSlow	2008-09-23
PMN K041284 | MQL ORIGIO A/S	IVM System	2008-09-23
PMN K031486 | MQL ORIGIO A/S	BlastFreeze & Thaw	2008-09-23
PMN K031228 | MQL ORIGIO A/S	SynVitro Hyadase	2008-09-23
PMN K003404 | MQL ORIGIO A/S	SupraSperm System	2008-09-23
PMN K003404 | MQL ORIGIO A/S	SupraSperm 100	2008-09-23
PMN K003163 | MQL ORIGIO A/S	SynVitro Flush	2008-09-23
PMN K060983 | MQL ORIGIO A/S	Biopsy Medium	2007-11-16

Similar & Related FDA Registered Companies

• Origio A/s, A CooperSurgical Company

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018082175779	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS CODE: 842199, 841990	18 CAS