Data / Medical devices / Taiwan / Bioteque Taiwan Ltd.
Bioteque Taiwan Ltd.: FDA-registered device maker in Xizhi Dist., New Taipei City, Taiwan, 10 510(k) clearances
Bioteque Taiwan Ltd. is registered with the FDA (registration 3003968049) in Xizhi Dist., New Taipei City, Taiwan. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 31, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003968049
- Address
- 7F., No. 431,433, Baozhang Rd., Xizhi Dist., New Taipei City, Taiwan, 221036
- Owner or operator
- Bioteque Taiwan Ltd. (10088630)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
- First device listed
- September 8, 2023
- Registered through
- 2027
- Brand names listed
- Bellota Sonohysterography Catheter, Cervical Dilator, Flexi Shelf Pessary, HSG Catheter Set, Pessary Remover, Silicon Inflatable Donut Pessary, The Curette and Preferred Curette, Uterine Injector 2/4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Curette, Suction, Endometrial (And Accessories) | HHK | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Complaint file establishment, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Dilator, Vaginal | HDX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Complaint file establishment, Contract sterilizer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 2018 | K173351 | Panpac Flexi Shelf Pessary | HHW | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| June 4, 2014 | K132670 | PANPAC INFLATABLE DOCUT PESSARY | HHW | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| January 10, 2014 | K130087 | PANPAC WORD/BARTHOLIN CATHETER | KNA | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| August 8, 2013 | K130273 | PANPAC VAGINAL DILATORS | HDX | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| December 15, 2011 | K102898 | BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| July 26, 2010 | K092982 | THE PANPAC SUCTION CURETTE | HHK | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| July 22, 2010 | K092981 | PANPAC VAGINAL PESSARY | HHW | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| June 7, 2010 | K092983 | PANPAC HSG CATHETER SET | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| April 7, 2010 | K092984 | PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| March 11, 2010 | K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Pessary, Vaginal
- All makers of Remover, Intrauterine Device, Contraceptive, Hook-Type
- All makers of Dilator, Vaginal
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Curette, Suction, Endometrial (And Accessories)
- All makers of Instrument, Manual, Specialized Obstetric-Gynecologic
Updated October 31, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.