5d ago
Sannuo Biotechnology: Announcement on Obtaining Medical Device Registration Certificate and Medical Device Registration Change
Securities code: 300298 Securities abbreviation: Sannuo Biotechnology Announcement number: 2026-088 Bond code: 123090 Bond abbreviation: Sannuo Convertible Bonds
Sannuo Biosensing Co., Ltd.
Announcement on Obtaining Medical Device Registration Certificate and Medical Device Registration Change
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.
Sannuo Biosensing Co., Ltd. (hereinafter referred to as the "Company") has recently received the "Medical Device Registration Certificate" and "Medical Device Change Registration (Filing) Document" issued by the State Food and Drug Administration and the Hunan Provincial Food and Drug Administration respectively. The specific situation is now announced as follows:
1. Main contents of medical device registration certificate
(1) Class III medical device registration certificate
Preface Registration Certificate Registration
Product name Registration certificate number Model, specification Scope of application/change content number Validity period Classification
This product can be used for continuous or periodic monitoring of interstitial fluid glucose levels in patients with diabetes mellitus (≥2 years). The product can provide and store real-time glucose values for users to track the trend of glucose concentration changes. If glucose 2026.09.04
Continuous glucose monitoring National Instruments approved level is below or above the preset reminder threshold, the product can be Category 1 to III H6-15s
Test system 20263071874 issues a reminder. This product is for single user use only, 2031.09.03
No user calibration is required, and the use time is up to 15 days. Product measurement results are not used as a basis for deciding and adjusting treatment plans for diabetic patients. The system is intended for use in healthcare facilities and home environments. (1) Change the structure and composition;
2024.12.13
Continuous glucose monitoring is approved by the National Instruments (2) Change of product technical requirements;
Category 2 to III H6/h6
Testing system 20243072505 (3) Change the product validity period;
2029.12.12
(4) Change product instructions.
(2) Class II medical device registration certificate
Preface Registration Certificate Registration
Product name Registration certificate number Intended use/scope of application/change content
No. Validity Classification
2026.10.20
Fluorescence immunoassay Xiang Mechanical Injection Standard and adapted specific dry test based on fluorescence immunochromatography Class 1 to II
It is equipped with instrument 20172220045 and is used for immunofluorescence detection of human samples.
2031.10.19
This product is used in conjunction with the matching blood glucose test strips for quantitative detection of glucose concentration in fresh capillary whole blood, venous whole blood, arterial whole blood and/or newborn whole blood. Can be used for medical treatment 2026.12.28 Institutions and/or families are approved for medical injection for diabetic patients, pregnant women, and kidney dialysis patients.
2 Blood Glucose Meters Rapid blood glucose testing for Class II or other populations. This product is only used for 20212222344
2031.12.27 Monitoring of blood sugar levels and preliminary screening of blood sugar abnormalities are not suitable for the final diagnosis of diabetes. The testing of venous whole blood, arterial whole blood and newborn whole blood must be performed by medical personnel. This product is not suitable for blood glucose testing of newborn umbilical cord blood samples.
Glycated hemoglobin
Test kit 2026.12.07
Hunan Machinery's Glycated Hemoglobin Detection Kit is used for in vitro quantitative detection 3 (boric acid affinity solution to class II
20212402203 The concentration of glycated hemoglobin (HbA1c) in human whole blood. Phase Chromatography/Chromatography 2031.12.06
law)
This product is mainly used for quantitative detection of glucose concentration in fresh capillary whole blood, venous whole blood, arterial whole blood and newborn whole blood. This product can be used for glucose and blood glucose test strips in hospitals or other medical institutions (Portuguese 2026.12.28
Hunan Mechanical Injection Approval Fast 4 glucose dehydrogenase method for patients with diabetes, pregnant women, renal dialysis patients or other groups/to Category II
20212402338 Rapid blood glucose test. This product is only used for monitoring blood sugar levels and dry chemical methods) 2031.12.27
The initial screening of blood sugar abnormalities is not suitable for the final diagnosis of diabetes. This product is not suitable for blood glucose testing of newborn umbilical cord blood samples.
This product is mainly used for quantitative detection of glucose concentration in fresh capillary whole blood, venous whole blood, arterial whole blood and newborn whole blood. This product can be used in hospitals or other medical institutions to treat sugar2026.12.28
Blood glucose test strips (dry, approved by Hunan Instruments, Category 5 to II for diabetic patients, pregnant women, renal dialysis patients or other groups of people)
Chemical method) 20212402340 Rapid blood glucose test. This product is only used for monitoring blood sugar levels and 2031.12.27
The initial screening of blood sugar abnormalities is not suitable for the final diagnosis of diabetes. This product is not suitable for blood glucose testing of newborn umbilical cord blood samples.
This product is mainly used for quantitative detection of glucose concentration in fresh capillary whole blood, venous whole blood and arterial whole blood. This product blood glucose test strip (Portuguese 2026.12.28) can be used for rapid blood glucose testing in hospitals or other medical institutions.
6 Glucose dehydrogenase to Class II Diabetic patients, pregnant women, renal dialysis patients or other groups 20212402341
Law) 2031.12.27 Self-monitoring of blood glucose. This product is only used for monitoring blood sugar levels and preliminary screening of blood sugar abnormalities, and is not suitable for the final diagnosis of diabetes. The testing of venous whole blood and arterial whole blood must be obtained by medical personnel. Registration Certificate Registration
Product name Registration certificate number Intended use/scope of application/change content
No. Validity Classification
operation.
This product is mainly used for quantitative detection of glucose concentration in fresh capillary whole blood, venous whole blood, arterial whole blood and newborn whole blood. This product can be used for rapid blood glucose test strips in hospitals or other medical institutions (Portuguese 2026.12.28 blood glucose test, diabetic patients, pregnant women, kidney dialysis patients or Hunan Medical Injection Approval
7 Glucose dehydrogenase to Category II Others perform self-monitoring of blood glucose. This product is only used for blood 20212402342
Law) 2031.12.27 Monitoring of sugar levels and preliminary screening of blood sugar abnormalities are not suitable for the final diagnosis of diabetes. The testing of venous whole blood, arterial whole blood and newborn whole blood must be performed by medical personnel. This product is not suitable for blood glucose testing of newborn umbilical cord blood samples.
This product is mainly used for quantitative detection of glucose concentration in fresh capillary whole blood, venous whole blood, arterial whole blood and newborn whole blood. This product can be used for glucose and blood glucose test strips in hospitals or other medical institutions (Portuguese 2026.12.28
Hunan Mechanical Injection Approval Fast 8 glucose dehydrogenase method for diabetic patients, pregnant women, renal dialysis patients or other groups/to category II
20212402343 Rapid blood glucose test. This product is only used for monitoring blood sugar levels and dry chemical methods) 2031.12.27
The initial screening of blood sugar abnormalities is not suitable for the final diagnosis of diabetes. This product is not suitable for blood glucose testing of newborn umbilical cord blood samples.
2026.03.22 (1) Change the structure and composition stated in the registration certificate;
Portable glycated blood test by Xiang Machinery
9 to Category II (2) Change the specifications and models stated on the registration certificate;
Red protein analyzer 20212220400
2031.03.21 (3) Change product technical requirements.
Blood glucose and uric acid test 2026.03.19
Xiang Machinery Injection
Article 10 (Electrochemical method/to Class II) (1) Change of product instructions.
20262400169
Dry chemical method) 2031.03.18
2026.03.19
Blood sugar and uric acid test
11 to Category II (1) Change product instructions.
Article (electrochemical method) 20262400170
2031.03.18
Items 1 to 8 in the above table refer to the continued registration of the medical device registration certificate that the company has obtained, and items 9 to
Item 11 is the change of the medical device registration certificate that the company has obtained.
2. Impact on the company
The new continuous glucose monitoring system product (H6-15s) approved by the State Food and Drug Administration this time,
Can be used for continuous or periodic monitoring of interstitial fluid glucose levels in diabetic patients 2 years of age and older, providing co-morbid
It stores real-time glucose values and tracks changing trends. It has a high and low glucose level reminder function and does not require user calibration. It can be used for up to 15 days. It is expected to be used in medical institutions and home environments.
The acquisition, extension and change of the above-mentioned medical device registration certificates have further enriched the categories and specifications of the company's testing products, optimized the technical parameters and performance of the products, helped ensure the compliance and sustainability of the company's products, better met the market's diversified testing needs, and continued to enhance the comprehensive competitiveness and market expansion capabilities of the company's products.
3. Risk warning
The actual sales of the products covered by the above-mentioned medical device registration certificates depend on the effect of future market promotion, and there is uncertainty about the impact on the company's future operating performance. Investors are kindly requested to invest with caution and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Sannuo Biosensing Co., Ltd.
September 8, 2026