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BD Automated Liquid-Based Thin Layer Smear Preparation and Dyeing System - Taiwan Registration 6bc4874ceff09bc3790e537b6ac9faff

Access comprehensive regulatory information for BD Automated Liquid-Based Thin Layer Smear Preparation and Dyeing System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 6bc4874ceff09bc3790e537b6ac9faff and manufactured by Plexus Manufacturing Sdn. Bhd.;; BECTON DICKINSON AND COMPANY. The authorized representative in Taiwan is BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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6bc4874ceff09bc3790e537b6ac9faff
Registration Details
Taiwan FDA Registration: 6bc4874ceff09bc3790e537b6ac9faff
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Device Details

BD Automated Liquid-Based Thin Layer Smear Preparation and Dyeing System
TW: BD่‡ชๅ‹•ๆถฒๅŸบ่–„ๅฑคๆŠน็‰‡่ฃฝ็‰‡ๆŸ“็‰‡็ณป็ตฑ
Risk Class 3

Registration Details

6bc4874ceff09bc3790e537b6ac9faff

DHA05602771604

Product Details

This product is a liquid-based, thin-layer cell preparation process, and the SurePath smear prepared with this product can be used to replace the traditional gynecological Pap smear. The SurePath smear can be used to screen and detect cervical cancer, precancerous lesions, atypical cells, and all other cytological classifications defined in the Bethesda System Cervical / Vaginal Cytology Diagnostic Classification Report.

B Hematology, pathology, and genetics

B.9999 Miscellaneous

import

Dates and Status

Oct 13, 2015

Oct 13, 2025