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膨体聚四氟乙烯颌面外科整形植入物Surgiform Augmentation Material膨体聚四氟乙烯颌面外科整形植入物 Surgiform Augmentation Material

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膨体聚四氟乙烯颌面外科整形植入物Surgiform Augmentation Material is a Other product (Class III device), registered by 美国射极峰科技有限公司Surgical Technology Laboratories, Inc.. Linked registrations: China 国械注进20173130604, China 国械注进20173460604. Data as of 2026-10-24.

  • Regulatory classOther · Class III device
  • Holder美国射极峰科技有限公司Surgical Technology Laboratories, Inc.
  • JurisdictionsCN
  • Updated2026-10-24 · v1

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

Registration and basics

膨体聚四氟乙烯颌面外科整形植入物Surgiform Augmentation Material

Product
Regulatory class
Class III device
Category
Other
China · NMPA device registration
国械注进20173130604
China · NMPA device registration
国械注进20173460604 (expired)
Registrant
美国射极峰科技有限公司Surgical Technology Laboratories, Inc.
China agent
北京仁诚鸿泰医疗器械有限公司
First approval
Not obtained from an official source
This certificate issued
2022-08-09
Valid until
2027-02-27
Models and sizes
eSH-371、eSH-771、eSH-7141、eSH-372、eSH-772、eSH-7142、eSH-373、eSH-773、eSH-7143、SFAM035、SFAM500、SFAM500A/B、SFAM501、SFAM502、SFAM503、SFAM600、SFAM600A/B、SFAM601、SFAM602…
Checked against official page
2026-10-23

Public: fields from the registration record.Registrant and dates are from 国械注进20173130604; 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20173460604 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20173130604 change

    官网变更：“注册人名称: Surgical Technology Laboratories, Inc.”变更为“注册人名称:Surgical Technology Laboratories, Inc. 美国射极峰科技有限公司”。

  3. CN

    国械注进20173130604 change

    官网变更：“注册人住所：610 Clemson Road. Columbia, SC 29229”变更为“注册人住所：1566 Whiting Way, Lugoff SC 29078,USA”。

  4. CN

    国械注进20173130604 change

    “注册人住所：610 Clemson Road. Columbia, SC 29229”变更为“注册人住所：1566 Whiting Way, Lugoff SC 29078,USA”。

  5. CN

    国械注进20173460604 valid until

  6. CN

    国械注进20173130604 this certificate issued

    Issue date of this certificate, not the first approval

  7. CN

    国械注进20173130604 change

    官网变更：一、产品结构及组成变化详见产品结构及组成变更对比表。二、产品技术要求变化详见产品技术要求变更对比表。

  8. CN

    国械注进20173130604 change

    一、产品结构及组成变化详见产品结构及组成变更对比表。二、产品技术要求变化详见产品技术要求变更对比表。

  9. CN

    国械注进20173130604 change

    延续或变更注册获批（受理号 JQY2600572；2026年07月30日医疗器械批准证明文件送达信息）

  10. CN

    国械注进20173130604 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20173130604: 延续或变更注册获批（受理号 JQY2600572；2026年07月30日医疗器械批准证明文件送达信息）2026-07-28
  • 国械注进20173130604: 官网变更：一、产品结构及组成变化详见产品结构及组成变更对比表。二、产品技术要求变化详见产品技术要求变更对比表。2024-09-23
  • 国械注进20173130604: 一、产品结构及组成变化详见产品结构及组成变更对比表。二、产品技术要求变化详见产品技术要求变更对比表。2024-09-23
  • 国械注进20173130604: certificate issued2022-08-09
  • 国械注进20173130604: “注册人住所：610 Clemson Road. Columbia, SC 29229”变更为“注册人住所：1566 Whiting Way, Lugoff S…2021-05-18

Sources

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