Data / Medical devices / China / Copioumed International, Inc.
Copioumed International, Inc.: FDA-registered device maker in TAIPEI Taiwan, China, 19 510(k) clearances
Copioumed International, Inc. is registered with the FDA (registration 9681151) in TAIPEI Taiwan, China. It lists 13 device types. The FDA files 19 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681151
- FEI number
- 3003792528
- Address
- 16F-4, No.1, Fuxing North Road Songshan District, TAIPEI Taiwan, China, 105
- Owner or operator
- COPIOUMED INTL., INC. (9019875)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- April 18, 1995
- Registered through
- 2027
- Brand names listed
- Copioumed Chemotherapy Isolation Gown, GENERIC, MULTIPLE LABELS, generic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Exporter to the US | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Exporter to the US | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Exporter to the US | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | QSO | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Exporter to the US | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| February 26, 2026 | K251860 | Copioumed AAMI 3 Surgical Gown | FYA | Substantially Equivalent | Copioumed International, Inc. | accessdata.fda.gov |
| October 4, 2023 | K230135 | Copioumed Chemotherapy Isolation Gown | FYC | Substantially Equivalent | Copioumed International, Inc. | accessdata.fda.gov |
| August 20, 2004 | K041945 | POWDER-FREE BLUE VINYL EXAM GLOVES | LYZ | Substantially Equivalent | Glormed Intl., Inc. | accessdata.fda.gov |
| June 10, 2003 | K031104 | POWDERED VINYL EXAM GLOVES, WHITE | LYZ | Substantially Equivalent | Glormed Intl., Inc. | accessdata.fda.gov |
| May 2, 2003 | K030997 | POWDERED VINYL EXAM GLOVES, WHITE | LYZ | Substantially Equivalent | Heyuan Hongli Industries, Inc. | accessdata.fda.gov |
| April 17, 2003 | K030927 | POWDERED VINYL EXAM GLOVES, WHITE | LYZ | Substantially Equivalent | Copioumed Intl., Inc. | accessdata.fda.gov |
| August 8, 2002 | K022305 | MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE | LYZ | Substantially Equivalent | Heyuan Hongli Industries, Inc. | accessdata.fda.gov |
| July 2, 2002 | K021961 | POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE | LYZ | Substantially Equivalent | Copioumed Intl., Inc. | accessdata.fda.gov |
| June 6, 2002 | K021353 | POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE | LYZ | Substantially Equivalent | Glormed Intl., Inc. | accessdata.fda.gov |
| June 5, 2001 | K011414 | POWDERED VINAL EXAM GLOVES | LYZ | Substantially Equivalent | Heyuan Hongli Industries, Inc. | accessdata.fda.gov |
| June 5, 2001 | K011413 | POWDER-FREE VINYL EXAM GLOVE, YELLOW | LYZ | Substantially Equivalent | Heyuan Hongli Industries, Inc. | accessdata.fda.gov |
| May 31, 2001 | K011412 | POWDER-FREE VINYL EXAM GLOVES | LYZ | Substantially Equivalent | Heyuan Hongli Industries, Inc. | accessdata.fda.gov |
| August 22, 2000 | K002340 | VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW | LYZ | Substantially Equivalent | Glormed Intl., Inc. | accessdata.fda.gov |
| November 5, 1998 | K983494 | VINYL EXAM GLOVES, POWDER FREE | LYZ | Substantially Equivalent | Glormed Intl., Inc. | accessdata.fda.gov |
| October 15, 1998 | K981360 | VINYL PATIENT EXAMINATION GLOVE, POWDERED | LYZ | Substantially Equivalent | Glormed Intl., Inc. | accessdata.fda.gov |
| September 3, 1997 | K970835 | FACE MASK, SURGICAL MASK, NON-STERILE | FXX | Substantially Equivalent | Tucker & Associates | accessdata.fda.gov |
| August 27, 1997 | K965237 | NURSES BOUFFANT CAP | LYU | Substantially Equivalent | Copioumed Intl., Inc. | accessdata.fda.gov |
| December 30, 1996 | K961342 | SHOE COVER, NON-STERILE | FXP | Substantially Equivalent | Copioumed Intl., Inc. | accessdata.fda.gov |
| December 30, 1996 | K960999 | ISOLATION GOWN | FYC | Substantially Equivalent | Copioumed Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shoe And Shoe Cover, Conductive
- All makers of Gown, Surgical
- All makers of Vinyl Patient Examination Glove
- All makers of Accessory, Surgical Apparel
- All makers of Suit, Surgical
- All makers of Gown, Isolation, Surgical
Updated February 26, 2026. 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.