乳房植入体Smooth Gel Breast Implants is a Breast implant product (Class III device), registered by 美诺医疗系统有限公司Mentor Medical Systems B.V.. Linked registrations: China 国械注进20173130340, China 国械注进20173460340. Data as of 2026-10-24.
Regulatory classBreast implant · Class III device
Holder美诺医疗系统有限公司Mentor Medical Systems B.V.
JurisdictionsCN · US · TW
Updated2026-10-24 · v1
Registration and basics are public; findings and prices need an account
Registration and basics
乳房植入体Smooth Gel Breast Implants
Product
Regulatory class
Class III device
Category
Breast implant
China · NMPA device registration
国械注进20173130340
China · NMPA device registration
国械注进20173460340 (expired)
Registrant
美诺医疗系统有限公司Mentor Medical Systems B.V.
China agent
强生（上海）医疗器材有限公司
First approval
Not obtained from an official source
This certificate issued
2021-12-01
Valid until
2027-01-21
Models and sizes
见附页
Checked against official page
2026-10-23
Public: fields from the registration record.Registrant and dates are from 国械注进20173130340; 2 registrations linked.
Label facts by jurisdiction
What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A
Mentor MemoryGel核心研究，初次隆乳，初期MRI组，10年：在Mentor MemoryGel核心研究初期MRI组初次隆乳病患中（已招募202位病患/417件植入物，10年随访89/195位病患），疑似或经确认破裂的10年Kaplan-Meier累积发生率为24.2%（95% CI 17.0–33.9，按病患数）。; Mentor MemoryGel核心研究，初次隆乳组（N=552），3/6年：初次隆乳组任何再次手术的3年累积Kaplan-Meier发生率为16.5%（95% CI 13.7–19.9），6年为20.1%（95% CI 17.0–23.7）。; Mentor MemoryGel核心研究，初次乳房重建组（N=251），3/6年：初次乳房重建组感染的3年累积Kaplan-Meier发生率为5.3%（95% CI 3.1–9.0），6年为5.8%（95% CI 3.5–9.6）。; Mentor MemoryGel核心研究，初次隆乳组（N=552），3/6年：初次隆乳组任何并发症（包括再次手术，排除破裂/无法确认的破裂）的3年累积Kaplan-Meier发生率为29.6%（95% CI 26.0–33.6），6年为37.7%（95% CI 33.8–41.9）。; Mentor MemoryGel核心研究，初次隆乳组（N=552），3/6年：初次隆乳组荚膜挛缩Baker III/IV的3年累积Kaplan-Meier发生率为8.2%（95% CI 6.2–10.9），6年为9.6%（95% CI 7.4–12.4）。
Each cell is extracted from that jurisdiction's label; click the number for the original passage. “—” means nothing has been extracted for it yet, not that the label is silent. Columns other than China reflect what was approved there, for reference only, not what China approved. 89 of them are not yet reviewed by a person.
Registration timeline
CN
国械注进20173460340 this certificate issued
Issue date of this certificate, not the first approval
CN
国械注进20173130340 change
官网变更：1.型号规格变更见附件“变更对比表”； 2.注册人名称由“Mentor Medical Systems B.V.”变更为“Mentor Medical Systems B.V.美诺医疗系统有限公司”； 3.技术要求变更见附件“其他”。
CN
国械注进20173130340 change
1.型号规格变更见附件“变更对比表”； 2.注册人名称由“Mentor Medical Systems B.V.”变更为“Mentor Medical Systems B.V.美诺医疗系统有限公司”； 3.技术要求变更见附件“其他”。
CN
国械注进20173130340 this certificate issued
Issue date of this certificate, not the first approval
First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.
乳房植入体Smooth Gel Breast Implants is a Breast implant product (Class III device), registered by 美诺医疗系统有限公司Mentor Medical Systems B.V.. Linked registrations: China 国械注进20173130340, China 国械注进20173460340. Data as of 2026-10-24.
Regulatory classBreast implant · Class III device
Holder美诺医疗系统有限公司Mentor Medical Systems B.V.
JurisdictionsCN · US · TW
Updated2026-10-24 · v1
Registration and basics are public; findings and prices need an account
Registration and basics
乳房植入体Smooth Gel Breast Implants
Product
Regulatory class
Class III device
Category
Breast implant
China · NMPA device registration
国械注进20173130340
China · NMPA device registration
国械注进20173460340 (expired)
Registrant
美诺医疗系统有限公司Mentor Medical Systems B.V.
China agent
强生（上海）医疗器材有限公司
First approval
Not obtained from an official source
This certificate issued
2021-12-01
Valid until
2027-01-21
Models and sizes
见附页
Checked against official page
2026-10-23
Public: fields from the registration record.Registrant and dates are from 国械注进20173130340; 2 registrations linked.
Label facts by jurisdiction
What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A
Mentor MemoryGel核心研究，初次隆乳，初期MRI组，10年：在Mentor MemoryGel核心研究初期MRI组初次隆乳病患中（已招募202位病患/417件植入物，10年随访89/195位病患），疑似或经确认破裂的10年Kaplan-Meier累积发生率为24.2%（95% CI 17.0–33.9，按病患数）。; Mentor MemoryGel核心研究，初次隆乳组（N=552），3/6年：初次隆乳组任何再次手术的3年累积Kaplan-Meier发生率为16.5%（95% CI 13.7–19.9），6年为20.1%（95% CI 17.0–23.7）。; Mentor MemoryGel核心研究，初次乳房重建组（N=251），3/6年：初次乳房重建组感染的3年累积Kaplan-Meier发生率为5.3%（95% CI 3.1–9.0），6年为5.8%（95% CI 3.5–9.6）。; Mentor MemoryGel核心研究，初次隆乳组（N=552），3/6年：初次隆乳组任何并发症（包括再次手术，排除破裂/无法确认的破裂）的3年累积Kaplan-Meier发生率为29.6%（95% CI 26.0–33.6），6年为37.7%（95% CI 33.8–41.9）。; Mentor MemoryGel核心研究，初次隆乳组（N=552），3/6年：初次隆乳组荚膜挛缩Baker III/IV的3年累积Kaplan-Meier发生率为8.2%（95% CI 6.2–10.9），6年为9.6%（95% CI 7.4–12.4）。
Each cell is extracted from that jurisdiction's label; click the number for the original passage. “—” means nothing has been extracted for it yet, not that the label is silent. Columns other than China reflect what was approved there, for reference only, not what China approved. 89 of them are not yet reviewed by a person.
Registration timeline
CN
国械注进20173460340 this certificate issued
Issue date of this certificate, not the first approval
CN
国械注进20173130340 change
官网变更：1.型号规格变更见附件“变更对比表”； 2.注册人名称由“Mentor Medical Systems B.V.”变更为“Mentor Medical Systems B.V.美诺医疗系统有限公司”； 3.技术要求变更见附件“其他”。
CN
国械注进20173130340 change
1.型号规格变更见附件“变更对比表”； 2.注册人名称由“Mentor Medical Systems B.V.”变更为“Mentor Medical Systems B.V.美诺医疗系统有限公司”； 3.技术要求变更见附件“其他”。
CN
国械注进20173130340 this certificate issued
Issue date of this certificate, not the first approval
First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.