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快速获证!landlink助力南京图格取得BSI签发的三维电子胸腹腔内窥镜MDR证书

  • 2026-07-06 22:47:29
快速获证!landlink助力南京图格取得BSI签发的三维电子胸腹腔内窥镜MDR证书

项目简介

Part.1

热烈祝贺南京图格医疗三维电子胸腹腔内窥镜，成功获得BSI签发的欧盟MDR认证证书，高效取得欧洲市场准入资格。

项目背景

Part.2

本次服务的三维电子胸腹腔内窥镜，用于胸腔、腹腔微创手术中，提供三维高清影像，供诊断、观察、手术治疗，合规要求严苛。洲通健康依托深耕行业二十载的资深法规团队、丰富的高难度项目实战经验，全程严格对标欧盟MDR法规要求，为客户提供合规解决方案。

服务期间，洲通团队秉持严谨高效、协同共进的服务理念，与客户紧密配合：

• 深度参与非临床部分资料的梳理与配合整改，确保技术文件完整合规；

• 全部临床部分资料的撰写与优化并提供专业的临床评价论证支持；

• 积极响应BSI互动式审核，针对审核提出的各项问题及时沟通、逐项落实。

凭借扎实的专业能力和成熟的审核应对经验，我们助力项目高效通过符合性评估，项目从开始审核到通过仅用2个月时间，彰显了洲通健康技术团队的专业水平和执行力。

本次认证的顺利完成，既是对南京图格产品技术实力的权威认可，也是洲通健康在微创外科器械合规领域专业能力与项目效率的有力印证。未来，洲通健康将继续以专业技术为核心，为医疗器械企业提供优质高效的合规服务，助力企业加速拓展全球市场。

再次恭喜南京图格取得BSI签发的MDR证书！

————            电话/微信联系 13127585853           ————

项目经验

Projects

首张 | Landlink助力海尔生物医疗获得TÜV莱茵签发的医用低温存储类设备MDR证书喜讯 | Landlink助力合作伙伴取得TÜV莱茵签发的一次性使用输尿管导引鞘MDR证书
III类植入器械获证 | Landlink助力合作伙伴协合医疗成功取得DNV签发的可吸收止血微球MDR证书
穿刺器获证 | Landlink助力世格赛思取得TÜV莱茵签发的一次性使用腹腔镜穿刺器MDR证书
牙科CBCT | Landlink助力合作伙伴取得美国FDA签发的510 K Clearance！Landlink助力正生瑞(ZSR)取得美国FDA签发的电子内镜及成像处理器510 K Clearance
药械组合产品获批 | Landlink助力合作伙伴的预灌封注射给药系统通过EMA认证新年再迎喜讯 | Landlink助力合作伙伴麦澜德成功获得MDSAP证书
植入类器械下证 | Landlink助力合作伙伴取得德凯签发的一次性使用止血夹MDR证书
电动吻合器产品获证 | Landlink助力合作伙伴贝恩外科取得TÜV莱茵签发的一次性电动腔镜吻合器MDR证书
Landlink助力合作伙伴取得德凯签发的电子支气管镜、输尿管镜、便携式电子内窥镜图像处理器MDR证书
内窥镜领域再下一证 | Landlink助力阿酷育医疗取得德凯签发的一次性宫腔电子内窥镜MDR证书
助力企业再次获证 | Landlink助力贝普医疗取得TÜV南德签发的配药用注射针、注射器等产品MDR证书
牙科影像设备下证 | Landlink助力合作伙伴中联海诺成功取得DNV签发的牙科X射线机MDR证书
Landlink助力合作伙伴成功取得德凯签发的胃肠道动力标记物胶囊MDR证书
输血器械耗材下证 | Landlink助力山东中保康取得TÜV南德签发的血浆分离器、去白细胞过滤器、无针注射器MDR证书！
Landlink助力徐州永康医疗成功取得TÜV南德签发的电子血压计、指夹式血氧仪、红外体温计产品MDR CE证书!
中国首张 | 牙科CBCT | Landlink助力朗视仪器成功取得口腔颌面锥形束计算机体层摄影设备MDR CE证书
非灭菌重复使用医疗器械 | Landlink助力上海凡超登成功取得TÜV莱茵签发的手用根管锉、机用根管锉MDR CE证书!
全面定制化服务 | Landlink助力合作伙伴淄博侨森取得TÜV南德签发的输血输液类耗材MDR CE证书！
全套网络安全测试 | Landlink助力合作伙伴取得美国FDA签发的彩色多普勒超声系统510 K Clearance
零发补通过！Landlink助力合作伙伴成功取得美国FDA签发的电子血压计510 K Clearance
血透领域再获新证！Landlink助力合作伙伴宝莱特成功取得TÜV南德签发的血液透析器MDR CE证书！

喜讯 | Landlink助力常美医疗取得TÜV南德签发的IIa类椎体扩张球囊导管MDR CE证书

新春开门红！Landlink助力英术生命科技取得FDA签发的一次性支气管镜510K Clearance

深度合作！Landlink助力合作伙伴成功取得TÜV莱茵签发的IIb类一次性使用单双极手术电极及IIa类可重复使用穿刺器MDR CE证书

Landlink助力健帆生物成功取得TÜV莱茵签发的IIb类一次性使用血液灌流器、一次性使用血浆胆红素吸附器MDR CE证书

超声器械获证 | Landlink助力旗声医疗成功取得BSI签发的全数字彩色超声诊断仪MDR证书

国内首张！Landlink助力声索生物取得FDA签发的超声内镜系统510K Clearance

国内首张！Landlink助力微创®畅行机器人获得BSI签发的关节置换机器人MDR CE认证

关于我们

Landlink汇聚了来自医疗器械法规、质量体系、测试等各领域对法规有深刻理解的资深人士及专家，致力于为医疗器械企业提供一站式、全方位、系统化的技术咨询服务， 帮助企业向全球市场提供安全、有效和合规的产品。

服务领域

国际注册服务：欧盟CE、美国FDA 510(K)、加拿大MDL/MDEL、澳大利亚TGA、巴西ANVISA、日本PMDA、沙特SFDA、俄罗斯RZN、其他国家注册服务、各国授权代表

中国注册服务：国内NMPA、进口注册、临床同品种比对

测试服务：测试咨询服务、网络安全测试/咨询、可用性测试/咨询、核磁兼容测试/咨询、功能安全测试/咨询

临床评价服务：临床评价报告撰写、真实世界数据、临床评价计划/报告、SOTA检索方案/报告

国际临床试验：上市后临床跟踪调研（PMCF）、临床试验中心筛选、国际临床试验服务

质量管理体系：MDR/IVDR、ISO 13485、MDSAP、NMPA GMP/GSP、 QSR 820、ISO 15378

代表产品服务领域

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  1. CONNECT:[ UseTime:0.001092s ] mysql:host=127.0.0.1;port=3306;dbname=b460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001692s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000647s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000590s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001227s ]
  6. SELECT * FROM `set` [ RunTime:0.000469s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001140s ]
  8. SELECT * FROM `article` WHERE `id` = 581018 LIMIT 1 [ RunTime:0.000868s ]
  9. UPDATE `article` SET `lasttime` = 1783390037 WHERE `id` = 581018 [ RunTime:0.005887s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000621s ]
  11. SELECT * FROM `article` WHERE `id` < 581018 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000993s ]
  12. SELECT * FROM `article` WHERE `id` > 581018 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000888s ]
  13. SELECT * FROM `article` WHERE `id` < 581018 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001633s ]
  14. SELECT * FROM `article` WHERE `id` < 581018 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.001338s ]
  15. SELECT * FROM `article` WHERE `id` < 581018 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.001585s ]
0.157366s