Biological Evaluation Products
Bofeimeike specializes in the R&D and services for biocompatibility testing of medical devices, with years of industry experience serving hundreds of healthcare institutions and corporate clients.
Product Line
Professional-grade biocompatibility testing products for medical devices, compliant with ISO, FDA, CE, and other international standards.
![[FDSC] Positive RM-F (sheet), Implantation Test (for short-term testing only), ZDEC](https://material-image.wanwang.xin/1210044392979308/public/878d5783-bbff-4003-877a-d7abdebe5c74.png)
[FDSC] Positive RM-F (sheet), Implantation Test (for short-term tests only), ZDEC
The RM series of reference plastic plates, developed jointly by the Food and Drug Safety Center (FDSC) and Hatano Research Institute in Japan, are widely used standard reference materials in the field of biological evaluation of medical devices. These RMs are included in the draft revision of the Japanese Basic Biological Testing Guidelines for Medical Devices (MHLW, Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
Freund's Complete Adjuvant
Freund's Complete Adjuvant (FCA)
![[FDSC] Negative Control, Rod, High-Density Polyethylene RM-E](https://material-image.wanwang.xin/1210044392979308/public/e39e7bad-60e8-4a37-8d76-caa688e2e787.png)
[FDSC] Negative Control, Rod, High-Density Polyethylene RM-E
The RM series of reference plastic plates, developed jointly by the Food and Drug Safety Center (FDSC) and Hatano Research Institute in Japan, are widely used standard reference materials in the field of biological evaluation of medical devices. These RMs are included in the draft revision of the Japanese Basic Biological Testing Guidelines for Medical Devices (MHLW, Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[FDSC] Positive Control RM-B (Sheet), ZDBC Polyurethane Film](https://material-image.wanwang.xin/1210044392979308/public/c56f0519-1368-46d2-be13-61f7c979807c.png)
[FDSC] Positive Control RM-B (sheet), ZDBC Polyurethane Film
The RM series of reference plastic plates, developed jointly by the Food and Drug Safety Center (FDSC) and Hatano Research Institute in Japan, are widely used standard reference materials in the field of biological evaluation of medical devices. These RMs are included in the draft revision of the Japanese Basic Biological Testing Guidelines for Medical Devices (MHLW, Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[FDSC] RM-H High-Density Polyethylene 2 mm × 100 mm (10 rods)](https://material-image.wanwang.xin/1210044392979308/public/e1273e87-209e-408d-a405-5122a7d261df.png)
[FDSC] RM-H High-Density Polyethylene 2 mm × 100 mm (10 rods)
The RM series of reference plastic plates, developed jointly by the Food and Drug Safety Center (FDSC) and Hatano Research Institute in Japan, are widely used standard reference materials in the field of biological evaluation of medical devices. These RMs are included in the draft revision of the Japanese Basic Biological Testing Guidelines for Medical Devices (MHLW, Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[FDSC] Negative Control RM-C (sheet), High-Density Polyethylene Film](https://material-image.wanwang.xin/1210044392979308/public/082d3e29-182b-4b2d-897a-8d9bd51ad376.png)
[FDSC] Negative Control RM-C (sheet), HDPF High-Density Polyethylene Film
The RM series of reference plastic plates, developed jointly by the Food and Drug Safety Center (FDSC) and Hatano Research Institute in Japan, are widely used standard reference materials in the field of biological evaluation of medical devices. These RMs are included in the draft revision of the Japanese Basic Biological Testing Guidelines for Medical Devices (MHLW, Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
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Special Topic
Specialized testing solutions for various medical fields
Use Cases
See how our products succeed in real-world medical testing
A Tier-3 Hospital Laboratory in Shanghai
Adopt Bofei Meike testing products; annual test volume exceeds 3000 cases.
Zhengzhou Medical Device Product Enterprise Cooperation
Long-term strategic partner for co-developing next-generation testing products
Suzhou Medical Device Testing Enterprise
Use Bofei Meike products for biocompatibility testing of medical devices.
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