Data / Medical devices / Denmark / Origio A/S
Origio A/S: FDA-registered device maker in Ballerup Hovedstaden, Denmark, 46 510(k) clearances
Origio A/S is registered with the FDA (registration 3004048494) in Ballerup Hovedstaden, Denmark. It lists 2 device types. The FDA files 46 510(k) clearances under its listings, the newest dated July 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004048494
- Address
- Lautrupvang 2, 1st, Ballerup Hovedstaden, Denmark, 2750
- Owner or operator
- ORIGIO A/S (9012179)
- Roles
- Specification developer
- First device listed
- November 16, 2007
- Registered through
- 2026
- Brand names listed
- Acidified Tyrodes Solution 1060, Biopsy Medium 1062, BlastAssist® 1215, 1216, BlastAssist® System 1039, 1040, 1045, 1047, BlastFreeze 1053, BlastThaw 1054, Blastgen 1205, CSC Freezing Medium ART-8017, CSC Thawing Medium ARt-8018 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | 2 | Specification developer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2020 | K200680 | Synvitro Hyadase | MQL | Substantially Equivalent | Origio A/S, A Coopersurgical Company | accessdata.fda.gov |
| May 4, 2018 | K180740 | VitriGuard | MQK | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| March 2, 2018 | K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) | MQL | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| March 2, 2018 | K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| October 13, 2017 | K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| February 16, 2017 | K162833 | VitriGuard | MQK | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| July 22, 2016 | K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| February 29, 2016 | K152932 | BlastGen | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| June 16, 2014 | K140317 | EMBRYOGEN | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| May 14, 2014 | K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| April 29, 2014 | K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| April 16, 2014 | K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| September 26, 2012 | K120136 | EMBRYOGEN | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| August 27, 2010 | K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| December 18, 2008 | K080172 | BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| October 10, 2008 | K073522 | VITRIFICATION KIT & VITRIFICATION WARMING KIT | MQL | Substantially Equivalent | Sage In-Vitro Fertilization, Inc. | accessdata.fda.gov |
| September 19, 2008 | K081639 | ICSI CUMULASE | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| September 3, 2008 | K080473 | EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| October 2, 2006 | K061145 | SPERMSLOW | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| July 28, 2006 | K060983 | BIOPSY MEDIUM, MODEL REF 1062 | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| July 14, 2006 | K053646 | INVITRO MATURATION MEDIA | MQL | Substantially Equivalent | Sage In-Vitro Fertilization, Inc. | accessdata.fda.gov |
| November 22, 2004 | K041284 | MEDICULT IVM SYSTEM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| August 20, 2003 | K030490 | ISM1+, IMS2+, AND UTM+ | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| June 27, 2003 | K031486 | BLASTFREEZE AND BLASTTHAW | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| June 24, 2003 | K031228 | SYNVITRO HYADASE | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| March 22, 2001 | K003404 | SUPRASPERM SYSTEM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| March 22, 2001 | K003163 | SYNVITRO FLUSH | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| March 22, 2001 | K003156 | BLASTASSIST SYSTEM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| December 21, 2000 | K003734 | SERUM PROTEIN SUBSTITUTE | MQL | Substantially Equivalent | Sage Biopharma | accessdata.fda.gov |
| October 3, 2000 | K002836 | MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE | MQL | Substantially Equivalent | Sage Biopharma | accessdata.fda.gov |
| July 20, 2000 | K991279 | MEDI-CULT UNIVERSAL IVF-MEDIUM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| May 4, 2000 | K991332 | MEDI-CULT SPERM PREPARATION - MEDIUM; | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| May 4, 2000 | K991327 | MEDI-CULT FLUSHING MEDIUM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| April 19, 2000 | K991380 | OIL FOR TISSUE CULTURE | MQL | Substantially Equivalent | Advanced Reproductive Technologies | accessdata.fda.gov |
| March 7, 2000 | K991470 | MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 28, 2000 | K991335 | MEDI-CULT FREEZING & THAWING PACKS | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 28, 2000 | K991333 | MEDI-CULT SPERM FREEZE MEDIUM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 25, 2000 | K991330 | MEDI-CULT LIQUID PARAFFIN | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 25, 2000 | K991329 | MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 7, 2000 | K991392 | HUMAN SERUM ALBUMIN | MQL | Substantially Equivalent | Advanced Reproductive Technologies | accessdata.fda.gov |
| February 2, 2000 | K991393 | HYALURONIDASE, 80 U/ML | MQL | Substantially Equivalent | Sage Biopharma | accessdata.fda.gov |
| February 2, 2000 | K991379 | QUINN'S SPERM WASHING MEDIUM | MQL | Substantially Equivalent | Advanced Reproductive Technologies | accessdata.fda.gov |
| January 18, 2000 | K991390 | 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI | MQL | Substantially Equivalent | Sage Biopharma | accessdata.fda.gov |
| January 10, 2000 | K991391 | PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF | MQL | Substantially Equivalent | Advanced Reproductive Technologies | accessdata.fda.gov |
| September 24, 1999 | K991381 | PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA | MQL | Substantially Equivalent | Pacific Andrology, Inc. | accessdata.fda.gov |
| September 24, 1999 | K991378 | PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED | MQL | Substantially Equivalent | Sage Biopharma | accessdata.fda.gov |
Compare with other makers
Updated July 17, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.