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Sign in to claim this brandBioteque Taiwan Ltd.
US
Last updated May 23, 2026
What Bioteque Taiwan Ltd. makes
Bioteque Taiwan Ltd. manufactures single-use and reusable medical devices for gynecological procedures, including pessaries for pelvic organ support, vaginal dilators for physical therapy, and intrauterine imaging medium catheters for diagnostic imaging. Their portfolio also includes uterine manipulators, endometrial biopsy kits, fixed-diameter cervical dilators, Bartholin’s gland catheters, and single-use uterine sounds. These devices are designed for use in clinical settings such as obstetrics, gynecology, and reproductive health diagnostics.
The company’s products are classified under FDA’s Class I and Class II categories, with most devices listed in the FDA’s Unique Device Identifier (UDI) database. While specific regulatory pathways vary by device type, they are intended for compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 657769858
Catalogue (248)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bioteque Taiwan Ltd. | HD2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | BA05F-ST | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | OV5 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | BA05F | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | SH7 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | M0014 | EUDAMEDFDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | Rs2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | M0016 | EUDAMEDFDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CUd0 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | FS12 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | GH4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CU2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | OV6 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | DSHs3 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | DSHs1 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | RKs2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | RKs6 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CUd10 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CUd4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | OVs2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | GD7 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | OVs4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | SH2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | RKs3 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | HD4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | RKs4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CPs5 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | OVs6 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CU0 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | HDs5 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | GD5 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | UIC5F | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CPs0 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | OVs1 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CUd1 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | OV4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | FS06 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | GH0 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CPs6 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | GS3 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | RK2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | Ms4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CU4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | M2 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CPs4 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | GH3 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | IR8 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | CU1 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | Ms6 | FDA UDI | Class II | Active |
| Bioteque Taiwan Ltd. | SH0 | FDA UDI | Class II | Active |
Related Companies
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Notified Bodies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bioteque Taiwan Ltd. Xizhi Dist., New Taipei City · TW FEI 3003968049