V-GRAD
Vitromed GmbH
VITROMED GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016126174 | 3016126174 | VITROMED GmbH | 1 | N | 2026-01-01 | Raiffeisen Str 15a Langenfeld (Rheinland) North Rhine-Westphalia DE 40764 |
| 3016214552 | 3016214552 | VITROMED GMBH | 1 | N | 2026-01-01 | Goschwitzer Str. 22 Jena Thuringia DE 07745 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 286321 | 1753534791 | K241833 | V-GRAD | MQL | 2025-03-21 |
| 286321 | 1816860906 | K240176 | V-VITFREEZE and V-VITWARM | MQL | 2024-09-13 |
| 286321 | 1099777390 | K232125 | V-PVP | MQL | 2024-03-20 |
| 286321 | 1719364124 | K223117 | V-SPERM WASH | MQL | 2023-01-31 |
| 286321 | 1501956394 | K222606 | V-HYADASE | MQL | 2023-05-26 |
| 286321 | 1448444318 | K213293 | V-HEPES PLUS | MQL | 2022-09-14 |
| 286321 | 1264200772 | K193285 | V-ONESTEP | MQL | 2020-11-20 |
| 236651 | 1632560393 | K192146 | V-DENUPET | MQH | 2020-01-28 |
| 286321 | 1632560393 | K192146 | V-DENUPET | MQH | 2020-01-28 |
| 236651 | 1690270901 | ||||
| 236651 | 1308771265 | ||||
| 286321 | 1308771265 | ||||
| 286321 | 1690270901 |
Product Codes Associated With Registrations#
PMN#
V-VITFREEZE and V-VITWARM
Vitromed GmbH
V-PVP
Vitromed GmbH
V-HYADASE
Vitromed GmbH
V-SPERM WASH
Vitromed GmbH
V-ONESTEP
Vitromed GmbH
V-DENUPET
Vitromed GmbH
GUDID#
V-GRAD 80 (2x for V-GRAD Kit) - V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.
2025-07-03
V-GRAD 40 (2x for V-GRAD Kit) - V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.
2025-07-03
V-GRAD 80 (2x for V-GRAD Kit) - V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.
2025-07-03
V-GRAD 40 - V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.
2025-07-03
V-GRAD 80 - V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.
2025-07-03
V-GRAD 100 - V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.
2025-07-03
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-DENUPET - The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
2022-03-01
V-VITWARM - V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently, the thawed oocytes and embryos can be used in Assisted Reproduction Technology (ART) processes. There are in total 4 vials of pink solutions in the package:- 2 vials of Thawing Solution (TS), with red caps and labels.- 1 vial of Diluent Solution (DS), with a yellow cap and label.- 1 vial of Washing Solution (WS), with a white cap and label.V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryosand blastocyst stage embryos.
2024-11-16
V-VITWARM - V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently, the thawed oocytes and embryos can be used in Assisted Reproduction Technology (ART) processes. There are in total 4 vials of pink solutions in the package: - 2 vials of Thawing Solution (TS), with red caps and labels. - 1 vial of Diluent Solution (DS), with a yellow cap and label. - 1 vial of Washing Solution (WS), with a white cap and label. V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
2024-11-16
V-VITFREEZE - V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Technology (ART). There are in total 3 vials of pink solutions in the package:-1 vial of Equilibration Solution (ES), with a blue cap and label.- 2 vials of Vitrification Solution (VS), with green caps and labels.V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
2024-10-16
V-VITFREEZE - V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Technology (ART). There are in total 3 vials of pink solutions in the package: -1 vial of Equilibration Solution (ES), with a blue cap and label. - 2 vials of Vitrification Solution (VS), with green caps and labels. V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
2024-10-16
V-PVP - V-PVP is a ready-to-use pharma grade polyvinylpyrrolidone (PVP) solution containing HEPES buffered Human Tubal Fluid (HTF) medium and Human Serum Albumin (HSA). V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
2024-05-04
V-ONESTEP - V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
2022-04-05
V-ONESTEP - V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
2022-04-05
V-ONESTEP - V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
2022-04-05
V-ONESTEP - V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
2022-04-04
V-CENTERWELL-60 - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-CULTUREDISH-60 - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-CULTUREDISH-90 - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-CULTUREDISH-35 - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-ICSIDISH-50 - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-4WELLDISH - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-HYADASE - V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contains Hyaluronidase in HEPES buffered Human Tubal Fluid (HTF) Medium with Human Serum Albumin (HSA).
2023-07-14
V-HYADASE - V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contains Hyaluronidase in HEPES buffered Human Tubal Fluid (HTF) Medium with Human Serum Albumin (HSA).
2023-07-14
V-SPERM WASH - V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim-up method and holdingsperm for IUI procedure.
2023-02-28
V-SPERM WASH - V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim-up method and holdingsperm for IUI procedure.
2023-02-28
V-HEPES PLUS - V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.
2022-12-30
V-SPERM MORPHO SLIDE - V-SMS-01
2022-12-16
V-DENUPET HANDLE - V-DH02
2022-12-16
V-CENTERWELL-60 - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-CULTUREDISH-60 - IVF Labware are ready-to-use plastic disposables.
2022-11-23
V-CULTUREDISH-90 - IVF Labware are ready-to-use plastic disposables.
2022-11-23