Trust & Certification
What Our Certifications Mean
Updated 2026-06-13 · Hotech Technical Team
In short
Hotech is certified to ISO 13485 medical-device quality management and Taiwan QMS, holds four TFDA medical-device licenses, and is registered with D-U-N-S. For procurement, this means documents can be verified, quality follows a system, and in-house purchasing review is easier.
ISO 13485: medical-device quality management
- ISO 13485 is a quality management standard designed specifically for medical devices, emphasizing design control, risk management and traceability more than general ISO 9001.
- For procurement, it means the supplier runs an audited quality system rather than case-by-case control.
Taiwan QMS and TFDA licenses
- Taiwan QMS covers medical-device quality management requirements; Hotech also holds four TFDA medical-device licenses (dry plasma thawing warmer, soft-line blood/fluid warmer, blood/fluid warmer, platelet storage container).
- License numbers can be verified through the TFDA medical-device license lookup system, and also appear on each product page.
D-U-N-S registration
- D-U-N-S is a globally recognized business identifier; registration means the company's identity and basic operations can be internationally verified, aiding cross-border procurement due diligence.
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FAQ
ISO 13485 vs. ISO 9001?
ISO 13485 is medical-device specific, emphasizing design control, risk management and traceability; ISO 9001 is a general quality standard.
How to verify a TFDA license?
Use the TFDA medical-device license lookup system, searching by license number or company name. Hotech's numbers appear on each corresponding product page.
What is D-U-N-S?
D-U-N-S is a unique global business identifier issued by Dun & Bradstreet, commonly used for international credit and supplier verification.