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Taiwan·TW-MF-000011340
Last updated May 27, 2026
What COPIOUMED INTERNATIONAL INC. makes
Copioumed International Inc. manufactures single-use protective and procedural garments, including isolation gowns, professional examination gowns, shoe covers, patient gowns, and surgical drapes designed for clinical and surgical environments. These products are intended to provide barrier protection against contamination and fluid exposure during medical procedures and patient care.
The company’s products are regulated as Class I and Class II medical devices, with listings in the EU’s eudamed database, the FDA’s 510(k) and UDI registries. Copioumed International Inc. is based in Taiwan.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Copioumed International Inc. manufacture?
Copioumed International Inc. specializes in single-use protective and procedural garments. These include isolation gowns for infection control, professional examination gowns for clinical use, shoe covers for contamination prevention, patient gowns for comfort and protection, and patient surgical drapes for sterile field maintenance. All are designed for clinical and surgical environments to reduce contamination risks.
Where is Copioumed International Inc. based, and how does that affect its regulatory compliance?
Copioumed International Inc. is based in Taiwan. While the company’s location influences its regulatory jurisdiction, its devices are classified under global standards (Class I and Class II) and are listed in key registries like the EU’s eudamed and the FDA’s 510(k) and UDI systems. Compliance depends on the device’s classification and the market requirements where they are sold, not the company itself.
Which regulatory registries list Copioumed International Inc.’s devices?
Copioumed International Inc.’s devices are included in the EU’s eudamed database and the FDA’s 510(k) premarket notification registry and UDI (Unique Device Identification) system. These registries track medical devices by classification and manufacturer details, ensuring transparency for regulators and healthcare providers. Listing in these systems reflects compliance with respective regional requirements.
How are Copioumed International Inc.’s devices classified under medical device regulations?
Copioumed International Inc.’s products are classified as either Class I or Class II medical devices. Class I devices generally pose minimal risk (e.g., basic protective garments) and often require general controls, while Class II devices involve moderate risk (e.g., surgical drapes) and may need special controls like performance standards or post-market surveillance. Classification determines regulatory oversight and compliance obligations.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Taiwan
- Address
- 1, 16F-4, No.1, Fuxing N. Rd., Songshan Dist., Taipei City 105, Taiwan (R.O.C.), Taipei, Taiwan
- Website
- www.copioumed-tw.com
- —
- —
- [email protected]
- Phone
- +886 2 27721815
- PRRC Contact
- Yuan-Kang Liu
- EUDAMED SRN
- TW-MF-000011340
- FDA FEI Number
- —
- DUNS Number
- 658318113
Catalogue (119)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Copioumed | MS031P | FDA UDI | Class II | Active |
| Copioumed | SCN0B171-1 | FDA UDI | Class I | Active |
| Copioumed | SCN0B201-1 | FDA UDI | Class I | Unknown |
| Copioumed | PEN1B101-1 | FDA UDI | Class I | Active |
| Copioumed | MS042W | FDA UDI | Class II | Active |
| Copioumed | SHN0W201-1 | FDA UDI | Class I | Active |
| Copioumed | SHN0B101-1 | FDA UDI | Class I | Active |
| Copioumed | CTN3B303-1 | FDA UDI | Class II | Active |
| Copioumed | PEN1B102-1 | FDA UDI | Class I | Active |
| Copioumed | MS042BL | FDA UDI | Class II | Active |
| Copioumed | LCN0B101-1 | FDA UDI | Class I | Active |
| Copioumed | IGN0P2060-1 | FDA UDI | Class II | Active |
| Copioumed | MS031B | FDA UDI | Class II | Active |
| Copioumed | SDS0B101-1 | FDA UDI | Class II | Active |
| Copioumed | MS031G | FDA UDI | Class II | Active |
| Copioumed | MS031W | FDA UDI | Class II | Active |
| Copioumed | MS041P | FDA UDI | Class II | Active |
| Copioumed | SCN0P171-1 | FDA UDI | Class I | Active |
| Copioumed | APN0X121-1 | FDA UDI | Class I | Active |
| Copioumed | MS042G | FDA UDI | Class II | Active |
| Copioumed | SHN0B111-1 | FDA UDI | Class I | Active |
| Copioumed | SCN0G181-1 | FDA UDI | Class I | Active |
| COPIOUMED Surgical Mask, Black, Tie-on style | MS022BL | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Surgical Mask, Blue, Earloop style | MS021B | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Warm-up JACKET, Blue, Set-in sleeves with plain pocket | JAN0B102-1 | EUDAMED | Class I | Active |
| COPIOUMED Medical Mask, Type II, Pink, Tie-on style | MS012P | EUDAMEDFDA UDI | Class I | Active |
| Copioumed Chemotherapy Isolation Gown | K230135 | FDA 510(k) | Class II | Active |
| Copioumed AAMI 3 Surgical Gown | K251860 | FDA 510(k) | Class II | Active |
| Copioumed Headwear, Blue, Surgical Cap | SCN0B501-1 | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Surgical Mask, Blue, Tie-on style | MS022B | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Medical Mask, Type II, Green, Tie-on style | MS012G | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Surgical Mask, Green, Tie-on style | MS022G | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Surgical Mask, Pink, Tie-on style | MS022P | EUDAMEDFDA UDI | Class I | Active |
| Copioumed Headwear, Blue, Surgical Cap | SCN0B131-1 | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Medical Mask, Type II, Green, Earloop style | MS011G | EUDAMEDFDA UDI | Class I | Active |
| Copioumed Headwear, Blue, Surgical Cap | SCN0B121-1 | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED, Warm-up JACKET, Blue, Set-in sleeves with plain pocket | JAN0B104-1 | EUDAMED | Class I | Active |
| Copioumed Headwear, Blue, Surgical Cap | SCN0B601-1 | EUDAMEDFDA UDI | Class I | Active |
| Copioumed Headwear, Blue, Surgical Cap | SCN0B901-1 | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED SCRUB SUITS, Blue, V-neckline shirt | SSN0B202-1 | EUDAMED | Class I | Active |
| Copioumed Headwear, Blue, Surgical Cap | SCN0B141-1 | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED, SCRUB SUITS, Blue, Drawstring Pants | DPN0B102-1 | EUDAMED | Class I | Active |
| COPIOUMED Surgical Mask, White, Earloop style | MS021W | EUDAMEDFDA UDI | Class I | Active |
| Copioumed Headwear, Blue, Surgical Cap | SCN0B161-1 | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Surgical Mask, Black, Earloop style | MS021BL | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Surgical Mask, Pink, Earloop style | MS021P | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Medical Mask, Type II, White, Tie-on style | MS012W | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Medical Mask, Type II, Pink, Earloop style | MS011P | EUDAMEDFDA UDI | Class I | Active |
| COPIOUMED Warm-up JACKET, Blue, Raglan sleeves with slant pocket | JAN0B204-1 | EUDAMED | Class I | Active |
| COPIOUMED Warm-up JACKET, Blue, Raglan sleeves with slant pocket | JAN0B201-1 | EUDAMED | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Copioumed International, Inc. TAIPEI Taiwan · CN FEI 3003792528