MQL
- 产品代码
- MQL
- 器械名称
- Media, Reproductive
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 884.6180
- FDA 专业组
- Obstetrics/Gynecology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 260 件
该代码近三年的 510(k)（24 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K254261 | 2026-08-28 | CELL STORE (BEIJING) BIOTECHNOLOGY CO. | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; 摘要 |
| K260248 | 2026-04-28 | Kitazato Corporation | Ultra-Fast Warm 摘要 |
| K252672 | 2026-02-20 | Casebioscience, Inc. | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/H 摘要 |
| K250445 | 2025-09-12 | Fujifilm Irvine Scientific | Fast Warm - NX 摘要 |
| K251637 | 2025-08-27 | Donnevie Medical Technology (Shanghai) | Dewin Reproductive Media (Dewin Gamete Buffer [with 摘要 |
| K251305 | 2025-08-26 | Kitazato Corporation | Ultra-Fast Vitri; Ultra-Fast Warm 摘要 |
| K242640 | 2025-05-30 | Fertipro NV | FertiCult Flushing medium; FertiCult Flushing medium 摘要 |
| K242561 | 2025-04-10 | Donnevie Medical Technology (Shanghai) | Dewin Reproductive Media (Dewin Vitrification Kit, D 摘要 |
| K242089 | 2025-04-10 | Jiangsu Ruifuda Medical Device Co., Lt | Vitrification Freeze Kit (RFD-0101) Vitrification Th 摘要 |
| K241833 | 2025-03-21 | Vitromed GmbH | V-GRAD 摘要 |
| K242107 | 2025-03-21 | Casebioscience, Inc. | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); 摘要 |
| K242043 | 2025-01-08 | Gimbo Medical Technology Shenzhen Co., | Sperm Freezing Medium |
| K241132 | 2024-12-18 | Artsmedia Denmark Aps | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 摘要 |
| K241095 | 2024-12-18 | Artsmedia Denmark Aps | ARTSMedia Semen Wash Medium 摘要 |
| K242968 | 2024-11-22 | Gimbo Medical Technology Shenzhen Co., | Giftlife® Single-Step Medium Plus |
| K240176 | 2024-09-13 | Vitromed GmbH | V-VITFREEZE and V-VITWARM 摘要 |
| K233846 | 2024-08-27 | Ecmpc, LLC | Vitrification Solution Set and Warming Solution Set 摘要 |
| K240605 | 2024-08-07 | Vitrolife Sweden AB | Ultra RapidWarm Blast 摘要 |
| K233477 | 2024-07-01 | Shandong Wego Ruisheng Medical Device | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B 摘要 |
| K240149 | 2024-06-13 | Gimbo Medical Technology Shenzhen Co., | Giftlife Fertilization Medium; Giftlife Cleavage M |
| K234023 | 2024-05-10 | Gimbo Medical Technology Shenzhen Co., | Oocyte Flushing & Retrieval Medium; Gamete Buffer |
| K233764 | 2024-04-24 | Fujifilm Irvine Scientific | SSS-NX (Serum Substitute Supplement-NX) 摘要 |
| K232125 | 2024-03-20 | Vitromed GmbH | V-PVP 摘要 |
| K232942 | 2024-01-30 | Gimbo Medical Technology Shenzhen Co., | G-Vitri Vitrification Freeze Media; G-Vitri Vitrif |
FDA 官方分类页： MQL
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。