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Credentials & Documents 资质文件

Original PDF records are provided for company and product fact verification. They are not medical advice and do not automatically prove that every product is approved for every country or market.

本页公开原始 PDF 用于公司与产品事实核验，不构成医疗建议，也不自动证明所有产品适用于所有国家或市场。

Company & Brand

Company & Brand / 公司与品牌

Business License

营业执照

undated

Issuer: Guilin Qixing District Market Supervision Administration
桂林市七星区市场监督管理局
Identifier: 91450305MAEJ0REC0K
Issue date: 2025-04-18
Valid until: Not stated in document
文件未载明有效期
Applies to: Guilin GuliXdent Medical Technology Co., Ltd.; company registration and permitted business scope
桂林古利氏医疗科技有限公司；公司登记及经营范围

Registers Guilin GuliXdent Medical Technology Co., Ltd. with unified social credit code 91450305MAEJ0REC0K and an address on the 4th floor of Building 4, Plot D-04-2a, Information Industry Park, Qixing District, Guilin.

载明桂林古利氏医疗科技有限公司统一社会信用代码 91450305MAEJ0REC0K，住所为桂林市七星区信息产业园D-04-2a地块4号楼四层。

Language: zh-CN · Pages: 1 · File size: 896 KB · Source pages: p.1

SHA-256: a52b63125039f90ba1a7f89e044a7d08566864bad0b8f70b5858502ddb55e1e7

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GuLix Class 10 Trademark Registration Certificate

GuLix 第10类商标注册证

valid

Issuer: China National Intellectual Property Administration
国家知识产权局
Identifier: 85865437
Issue date: 2026-01-28
Valid until: 2036-01-27
2036-01-27
Applies to: GuLix trademark; Nice Classification class 10 goods listed in the certificate, including medical devices and instruments and dental equipment and instruments
GuLix 商标；证书所列第10类商品，包括医疗器械和仪器、牙科设备和仪器等

Confirms registration of the GuLix trademark under registration no. 85865437 for the class 10 goods listed in the certificate, including medical devices and instruments and dental equipment and instruments, valid from 28 January 2026 to 27 January 2036.

确认 GuLix 商标第85865437号在证书所列第10类商品上的注册，包括医疗器械和仪器、牙科设备和仪器等，注册日期为2026年1月28日，有效期至2036年1月27日。

Language: zh-CN · Pages: 1 · File size: 892 KB · Source pages: p.1

SHA-256: 42d19480a086754d86af8380d356cf37ef1f83e6ab25ccd045e7ac7ec79edfc2

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GuLix Trademark Registration Certificate

GuLix 商标注册证

valid

Issuer: China National Intellectual Property Administration
国家知识产权局
Identifier: 85877525
Issue date: 2026-01-28
Valid until: 2036-01-27
2036-01-27
Applies to: GuLix trademark; Nice Classification class 35 goods/services listed in the certificate
GuLix 商标；证书所列第35类商品/服务项目

Confirms registration of the GuLix trademark under registration no. 85877525 for class 35 services, valid from 28 January 2026 to 27 January 2036.

确认 GuLix 商标第85877525号在第35类服务项目上的注册，注册日期为2026年1月28日，有效期至2036年1月27日。

Language: zh-CN · Pages: 1 · File size: 893 KB · Source pages: p.1

SHA-256: 63ed9c59d3da754ff50e09221ecffb27e20f5606c9d1488474492cc18ef58769

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Medical Device Regulatory Records

Medical Device Regulatory Records / 医疗器械监管

Class I Medical Device Filing Information Form

第一类医疗器械备案信息表

undated

Issuer: Guilin Market Supervision Administration
桂林市市场监督管理局
Identifier: 桂桂械备20250065
Issue date: 2026-05-11
Valid until: Not stated in document
文件未载明有效期
Applies to: Dental alginate impression material; General, Crystal and Ceramic purposes in 454 g/bag and 1000 g/bag sizes
藻酸盐复制材料；通用、水晶、烤瓷，454g/袋和1000g/袋规格

Lists dental alginate impression material under filing no. 桂桂械备20250065, with intended use for laboratory model-duplicating impressions.

备案编号桂桂械备20250065，产品名称为藻酸盐复制材料，预期用途为技工室复制印模（制取模型的印模）。

Language: zh-CN · Pages: 1 · File size: 103 KB · Source pages: p.1

SHA-256: 910a9ff3539521797da23063e0ca13116ce34cd075def8a0fa7b468f54d94ed5

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Class I Medical Device Production Filing Voucher

第一类医疗器械生产备案凭证

undated

Issuer: Guilin Market Supervision Administration
桂林市市场监督管理局
Identifier: 桂桂药监械生产备20260005号
Issue date: 2026-05-14
Valid until: Not stated in document
文件未载明有效期
Applies to: Class I production scope: 17-09-07 impression materials
Ⅰ类生产范围：17-09-07印模材料

Records the company’s Class I medical device production filing for production scope 17-09-07 impression materials.

载明企业第一类医疗器械生产备案，生产范围为Ⅰ类：17-09-07印模材料。

Language: zh-CN · Pages: 1 · File size: 433 KB · Source pages: p.1

SHA-256: 95808c634829a0e5d7ea1a464155ada160a2a21b0e1197012c7989055980beff

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Class II Medical Device Business Filing Voucher

第二类医疗器械经营备案凭证

undated

Issuer: Guilin Market Supervision Administration
桂林市市场监督管理局
Identifier: 桂桂药监械经营备20250361号
Issue date: 2025-12-01
Valid until: Not stated in document
文件未载明有效期
Applies to: Medical device wholesale and retail operation categories listed in the filing voucher
备案凭证所列医疗器械批零兼营范围

Records Class II medical device wholesale and retail business filing no. 桂桂药监械经营备20250361号 for Guilin GuliXdent Medical Technology Co., Ltd.

载明桂林古利氏医疗科技有限公司第二类医疗器械批零兼营备案，备案编号桂桂药监械经营备20250361号。

Language: zh-CN · Pages: 1 · File size: 413 KB · Source pages: p.1

SHA-256: ae9f817cd5ccff71dcb67a4214041ebf255ec05e939d20d9cbb44d5c70ad09f4

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Medical Device Online Sales Record Voucher

医疗器械网络销售信息凭证

undated

Issuer: Guilin Market Supervision Administration
桂林市市场监督管理局
Identifier: （桂桂）网械销售字〔2025〕第00165号
Issue date: 2025-12-03
Valid until: Not stated in document
文件未载明有效期
Applies to: Medical device online sales through listed third-party platforms Taobao and Pinduoduo Mall
通过淘宝、拼多多商城等凭证所列第三方平台开展医疗器械网络销售

Records online medical device sales information no. （桂桂）网械销售字〔2025〕第00165号 and identifies Taobao and Pinduoduo Mall as listed third-party platforms.

载明医疗器械网络销售信息号（桂桂）网械销售字〔2025〕第00165号，并列明淘宝、拼多多商城等第三方平台。

Language: zh-CN · Pages: 2 · File size: 1.4 MB · Source pages: pp.1-2

SHA-256: 477887e1b56714359f360bcfb4d9b91f98692d8218ac8ee45f9f1bdf777c6655

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Export & EU Documents

Export & EU Documents / 出口与欧盟文件

Certificate for Exportation of Medical Products

医疗器械产品出口销售证明

valid

Issuer: Guangxi Medical Products Administration
广西壮族自治区药品监督管理局
Identifier: 桂药监械出20250175号 / 20250175
Issue date: 2025-12-10
Valid until: 2027-12-09
2027-12-09
Applies to: Dental alginate impression material; General, Crystal and Ceramic purposes in 454 g/bag and 1000 g/bag sizes
藻酸盐复制材料；通用、水晶、烤瓷，454g/袋和1000g/袋规格

States that dental alginate impression material has been registered to be manufactured and sold in China, with certification valid until 9 December 2027.

证明藻酸盐复制材料已准许在中国生产和销售，证明有效日期至2027年12月9日。

Language: zh-CN/en · Pages: 1 · File size: 532 KB · Source pages: p.1

SHA-256: 12643b1cafaf7c8ea892bde10284a4694ec48c4890ed3f0bad31aad4e47b05bd

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EU Authorized Representative and Declaration of Conformity

欧盟授权及符合性声明

undated

Issuer: SKIRGESA Ltd. / GULIXDENT INC.
SKIRGESA Ltd. / GULIXDENT INC.
Identifier: SRN: LT-IM-000004084; Technical Documentation HJY-CE-A/9-2021; UDI 697068808HYGESM
Issue date: 2025-02-06
Valid until: Not stated in document
文件未载明有效期
Applies to: Alginate Impression Material; specified names include Gulixdent, Chromatic, GulixChroma, Gulix and GulixPLUS Alginate Impression Material
Alginate Impression Material；列名包括 Gulixdent、Chromatic、GulixChroma、Gulix、GulixPLUS Alginate Impression Material

Includes an EU authorized representative certificate naming SKIRGESA Ltd. and a declaration of conformity for Alginate Impression Material under MDR 2017/745, dated 6 February 2025 on the declaration page.

包含 SKIRGESA Ltd. 欧盟授权代表文件，以及依据 MDR 2017/745 出具的 Alginate Impression Material 符合性声明；声明页日期为2025年2月6日。

Language: en · Pages: 2 · File size: 790 KB · Source pages: pp.1-2

SHA-256: 0d3c1ac5fcf84ae7c5a28b21b2d66c7c9e14c21a205e490d4f640c28b03879a5

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Safety & Transport Documents

Safety & Transport Documents / 安全与运输

Hazard Classification and Identification Report for Sea Transport

运输危险性鉴定书（海运）

valid

Issuer: Shanghai Institute of Chemical Industry Testing Co., Ltd.
上海化工院检测有限公司
Identifier: NO.202600217581539
Issue date: 2025-12-20
Valid until: 2026-12-31
2026-12-31
Applies to: Dental alginate impression material / 藻酸盐复制材料; sea transport under IMO IMDG Code (2024 Edition)
藻酸盐复制材料 / Dental alginate impression material；按 IMO IMDG Code（2024版）海运

Concludes that the product is not subject to the IMO IMDG Code for sea transport, with no hazards identification and no packing group.

鉴定结论载明危险性识别为无，包装类别为无，海运可按非限制性货物条件办理。

Language: zh-CN/en · Pages: 4 · File size: 2.2 MB · Source pages: pp.1-4

SHA-256: f2214752485078f347719cc903be862b784226782fe2a2e769e6adbf047131ee

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