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ArteCollArteColl Collagen & PMMA Subdermal Implant System

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ArteColl is a PMMA microspheres product (Class III device), registered by 荷兰汉福生物科技公司Hafod Bioscience B.V.. Linked registrations: China 国械注进20163132859, China 国械注进20163462859. Data as of 2026-10-24.

  • Regulatory classPMMA microspheres · Class III device
  • Holder荷兰汉福生物科技公司Hafod Bioscience B.V.
  • JurisdictionsCN
  • Updated2026-10-24 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

ArteColl

Product
Regulatory class
Class III device
Category
PMMA microspheres
China · NMPA device registration
国械注进20163132859
China · NMPA device registration
国械注进20163462859 (expired)
Name on registration
整形用胶原和PMMA皮下植入物系统ArteColl
Registrant
荷兰汉福生物科技公司Hafod Bioscience B.V.
China agent
广东友邦医药有限公司
First approval
Not obtained from an official source
This certificate issued
2021-10-26
Valid until
2026-10-25
Models and sizes
0.5ml，0.1ml
Checked against official page
2026-10-24

Public: fields from the registration record.Registrant and dates are from 国械注进20163132859; 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

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Registration timeline

  1. CN

    国械注进20163462859 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20163132859 change

    官网变更：“代理人名称：广东省医药保健品进出口公司；代理人住所：广州市越秀区执信南路10号 ”变更为“代理人名称：山东华瑞丰经贸有限公司；代理人住所：济南市商河县商西路7号”。

  3. CN

    国械注进20163132859 change

    官网变更：“注册人名称：Hafod Bioscience B.V.；代理人名称：山东华瑞丰经贸有限公司；代理人住所：济南市商河县商西路7号;”变更为“注册人名称：Hafod Bioscience B.V.,荷兰汉福生物科技公司；代理人名称：广东友邦医药有限公司；代理人住所：佛山市…

  4. CN

    国械注进20163462859 change

    官网变更：“注册人名称：Hafod Bioscience B.V.；代理人名称：山东华瑞丰经贸有限公司；代理人住所：济南市商河县商西路7号;”变更为“注册人名称：Hafod Bioscience B.V.,荷兰汉福生物科技公司；代理人名称：广东友邦医药有限公司；代理人住所：佛山市…

  5. CN

    国械注进20163462859 change

    “注册人名称：Hafod Bioscience B.V.；代理人名称：山东华瑞丰经贸有限公司；代理人住所：济南市商河县商西路7号;”变更为“注册人名称：Hafod Bioscience B.V.,荷兰汉福生物科技公司；代理人名称：广东友邦医药有限公司；代理人住所：佛山市禅城区石湾…

  6. CN

    国械注进20163132859 change

    官网变更：“代理人住所：佛山市禅城区石湾镇街道深村田心村南大街12号A座2楼”变更为“代理人住所：佛山市禅城区石湾镇街道深村田心村南大街12号A座二楼（201-206室）（住所申报）”。

  7. CN

    国械注进20163462859 change

    官网变更：“代理人住所：佛山市禅城区石湾镇街道深村田心村南大街12号A座2楼”变更为“代理人住所：佛山市禅城区石湾镇街道深村田心村南大街12号A座二楼（201-206室）（住所申报）”。

  8. CN

    国械注进20163462859 change

    “代理人住所：佛山市禅城区石湾镇街道深村田心村南大街12号A座2楼”变更为“代理人住所：佛山市禅城区石湾镇街道深村田心村南大街12号A座二楼（201-206室）（住所申报）”。

  9. CN

    国械注进20163462859 valid until

  10. CN

    国械注进20163132859 this certificate issued

    Issue date of this certificate, not the first approval

  11. CN

    国械注进20163132859 change

    官网变更：<p style="font-size:18.7px;font-family:宋体"><span style="font-size:18px;">1.结构组成由:“该产品为含聚甲基丙烯酸甲酯（PMMA）微球体的胶原蛋白悬浮液，含微量利多卡因，预装在注射器中。其中胶原蛋白…

  12. CN

    国械注进20163462859 change

    官网变更：<p style="font-size:18.7px;font-family:宋体"><span style="font-size:18px;">1.结构组成由:“该产品为含聚甲基丙烯酸甲酯（PMMA）微球体的胶原蛋白悬浮液，含微量利多卡因，预装在注射器中。其中胶原蛋白…

  13. CN

    国械注进20163462859 change

    <p style="font-size:18.7px;font-family:宋体"><span style="font-size:18px;">1.结构组成由:“该产品为含聚甲基丙烯酸甲酯（PMMA）微球体的胶原蛋白悬浮液，含微量利多卡因，预装在注射器中。其中胶原蛋白来自澳大利…

  14. CN

    国械注进20163132859 change

    延续或变更注册获批（受理号 JQY2600226；2026年05月26日医疗器械批准证明文件送达信息）

  15. CN

    国械注进20163132859 valid until

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.

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Recent changes

5
  • 国械注进20163132859: 延续或变更注册获批（受理号 JQY2600226；2026年05月26日医疗器械批准证明文件送达信息）2026-05-22
  • 国械注进20163132859: 官网变更：<p style="font-size:18.7px;font-family:宋体"><span style="font-size:18px;">1.…2021-11-22
  • 国械注进20163462859: 官网变更：<p style="font-size:18.7px;font-family:宋体"><span style="font-size:18px;">1.…2021-11-22
  • 国械注进20163462859: <p style="font-size:18.7px;font-family:宋体"><span style="font-size:18px;">1.结构组成由…2021-11-22
  • 国械注进20163132859: certificate issued2021-10-26

Sources

2