Core Viewpoint - The company, Weili Medical (603309.SH), has received notification from the EU announcement agency regarding the addition of multiple products to its EU Medical Device Regulation (MDR) certification, indicating compliance with the latest EU medical device regulations and enabling legal sales in relevant overseas markets [1] Group 1 - The company has obtained EU MDR certification for several products, which signifies adherence to the latest EU medical device regulatory requirements [1] - The new certification allows the company to meet the latest market access conditions in the EU, facilitating the promotion and sales of its products in corresponding markets [1]

维力医疗公告称，近日公司欧盟医疗器械法规（MDR）认证证书新增多个产品的欧盟MDR认证。包括 Ⅰ类灭菌的导尿管护理包等产品、Ⅱa类的微网雾化器（耗材）等产品、Ⅱb类的导尿包等产品，发证机 构均为TÜVSÜD Product Service GmbH，证书签批时间多为2026/2/3，到期时间在2028年。获认证表明 产品符合欧盟法规要求，具备欧盟市场准入条件，利于产品推广销售，但无法预测对未来业绩的具体影 响。 ...

（编辑 袁冠琳） 证券日报网1月30日讯 ，维力医疗在接受调研者提问时表示，经初步测算，预计印尼工厂的单位生产成 本比国内高出约10%。目前，客户对于印尼出货产品的报价高于国内出货产品，客户所提价格基本能够 覆盖生产成本的增加。在印尼工厂正式投产后，公司将根据印尼工厂的实际生产成本，在维持原有产品 毛利率水平不变的前提下，与客户进一步协商，以确定印尼工厂出货产品的价格。预计将生产转移至印 尼不会对公司产品的毛利率产生显著影响。 ...

Core Viewpoint - The company, Weili Medical, has reported a significant decline in the operating performance of its wholly-owned subsidiary, Jiangxi Langhe Medical Equipment Co., Ltd. (referred to as "Langhe Medical"), due to a slowdown in product market demand and intense industry competition [2] Group 1: Company Performance - The operating performance of Langhe Medical has been severely impacted, leading to a substantial decline in its financial results [2] - Weili Medical acquired 100% of Langhe Medical's shares in 2018, resulting in goodwill amounting to 26,936.70 million yuan [2] - The management has preliminarily assessed that the goodwill from the acquisition shows signs of impairment based on the current operating conditions and future forecasts [2] Group 2: Financial Adjustments - To reflect the company's financial status and asset value more objectively, it plans to recognize a goodwill impairment of 14,700 million yuan for the fiscal year 2025 [2] - The final impairment amount will be determined after evaluation and audit by appointed assessment and auditing agencies [2]

Core Viewpoint - The company, Weili Medical, is expanding its production capacity in Indonesia, focusing on medical products primarily for the U.S. market [1] Group 1: Production Capacity - The first phase of the Indonesian factory is designed to produce 40 million units of nursing products, specifically suction connection tubes with attract heads, all intended for a major U.S. client [1] - The second phase of production will include anesthetic products such as tracheal tubes and laryngeal masks, as well as urinary products like silicone catheters, also aimed at the U.S. market [1] Group 2: Future Plans - The company plans to adjust its production capacity for other anesthetic, urinary, and nursing products based on local market demand in Indonesia and the status of its overseas business expansion [1]

Core Viewpoint - The company has maintained a prudent approach to foreign exchange management, which minimizes the impact of currency fluctuations on overall performance [1] Group 1: Foreign Exchange Management - The company conducts regular settlements of foreign currencies and implements robust measures to mitigate exchange rate risks [1] - A portion of the overseas major clients conducts business transactions in Renminbi, further reducing the impact of currency volatility [1] - Overall, the influence of exchange rate fluctuations on the company's performance is generally limited [1]

Core Viewpoint - The medical device sector experienced a rise of 0.54% on January 21, with N Aisheren leading the gains, while the Shanghai Composite Index increased by 0.08% and the Shenzhen Component Index rose by 0.7% [1] Group 1: Stock Performance - N Aisheren (code: 920050) closed at 44.04, with a remarkable increase of 175.59% and a trading volume of 141,600 shares [1] - Tianzhihang (code: 688277) saw a rise of 12.38%, closing at 23.88 with a trading volume of 376,500 shares [1] - Xishan Technology (code: 688576) increased by 11.18%, closing at 76.80 with a trading volume of 34,000 shares [1] - Kangzhong Medical (code: 688607) rose by 10.91%, closing at 59.67 with a trading volume of 76,200 shares [1] - Shuoshi Biological (code: 6658889) increased by 9.74%, closing at 84.84 with a trading volume of 70,300 shares [1] Group 2: Capital Flow - The medical device sector saw a net inflow of 300 million yuan from institutional investors, while retail investors experienced a net outflow of 430 million yuan [2] - Major stocks like Sainuo Medical (code: 688108) had a net inflow of 69.18 million yuan from institutional investors, but a net outflow of 44.76 million yuan from retail investors [3] - LePu Medical (code: 300003) had a net inflow of 48.54 million yuan from institutional investors, with a slight net inflow of 0.52 million yuan from retail investors [3]

Core Viewpoint - The sixth batch of national organized high-value medical consumables centralized procurement results have been announced, including 12 types of medical consumables, with execution expected around May 2026. The long-term growth potential of the high-value consumables sector is viewed positively due to the continuous increase in surgical and diagnostic volumes driven by aging populations and gradual import substitution [1]. Group 1: Event Details - On January 13, the results of the sixth batch of national organized high-value medical consumables centralized procurement were announced in Tianjin, involving 12 types of medical consumables, with 496 products from 227 companies bidding and 440 products from 202 companies winning [1]. - The procurement includes drug-coated balloons and urological intervention consumables, with a high selection ratio for the bidding products [2]. Group 2: Selection Process Optimization - The selection rules have been optimized to ensure that clinically recognized and capable products are chosen, stabilizing clinical usage [3]. - For differentiated products with certain functional innovations, a pricing coefficient based on clinical value has been established to reflect price differences reasonably [3]. - The lowest price is not the sole criterion for selection; if the lowest price is excessively low, a control benchmark of 65% of the average entry price is applied [3]. Group 3: Related Listed Companies - Companies related to coronary drug balloons include Lepu Medical, Blue Sail Medical, and MicroPort Medical [4]. - For peripheral drug balloons, companies such as Xianruida Medical-B, Gree创通桥, Xinmai Medical, and Lepu Medical are involved [4]. - In the urological intervention category, companies like Weili Medical and Weigao Group have all won bids, with examples of winning prices showing moderate reductions compared to earlier procurements [4].

Group 1 - The core viewpoint of the article is that Weili Medical has been actively exporting to the European market, with projected revenue from this segment accounting for approximately 15% of its main business income in 2024 [1] - Weili Medical confirmed that its sales to the European market are primarily conducted through direct exports from domestic entities to European customers, with a smaller portion facilitated by third-party traders or agents [1]

Group 1 - The core viewpoint of the article is that Weili Medical (603309) has a significant presence in the European market, with exports expected to account for approximately 15% of its main business revenue in 2024 [1] - The company primarily exports directly to European customers from domestic sources, with a small portion of sales conducted through third-party traders or agents [1]