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Sign in to claim this brandMEDITIME CO., LTD.
US
Last updated May 24, 2026
What MEDITIME CO., LTD. makes
Meditime Co., Ltd. manufactures bioabsorbable polyester sutures, including monofilament and non-antimicrobial variants, used for internal tissue approximation and wound closure.
The company’s products are classified as Class II devices and are listed under FDA’s 510(k) and UDI programs. 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.
Frequently asked questions
What types of medical devices does Meditime Co., Ltd. primarily manufacture?
Meditime Co., Ltd. specializes in bioabsorbable polyester sutures, specifically monofilament and non-antimicrobial variants. These sutures are designed for internal tissue approximation and wound closure, dissolving naturally over time without requiring removal.
Where is Meditime Co., Ltd. based, and how does that affect its regulatory oversight?
Meditime Co., Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s 510(k) and UDI programs, ensuring compliance with U.S. medical device standards.
Which regulatory registries or databases list Meditime Co., Ltd.’s devices?
Meditime Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identification (UDI) system. These registries help track and verify the compliance and classification of their Class II sutures.
How are Meditime Co., Ltd.’s devices classified under U.S. regulations?
Meditime Co., Ltd.’s sutures are classified as Class II devices under FDA regulations. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as bioabsorbable sutures.
AI-generated from registry data 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
- 689774482
Catalogue (78)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Viola | DV2044BS10ED | FDA UDI | Class II | Active |
| Les Encres | DVCHR19038L-00040X | FDA UDI | Class II | Active |
| Les Encres | DVSRR21100W-30150X | FDA UDI | Class II | Active |
| Les Encres | DVPXS25060C-70080X | FDA UDI | Class II | Active |
| Viola | DVAGR18100L-02170X | FDA UDI | Class II | Active |
| Viola | DVMXB23050L-60070X | FDA UDI | Class II | Active |
| Viola | DVMXR27038C-50050X | FDA UDI | Class II | Active |
| Viola | DVNXR19038L-60040X | FDA UDI | Class II | Active |
| Viola | DVSSR20100L-20165X | FDA UDI | Class II | Active |
| Viola | DVCGR19100L-00200X | FDA UDI | Class II | Active |
| Viola | DVSSR19100L-00165X | FDA UDI | Class II | Active |
| Les Encres | DVMXR27025C-50030X | FDA UDI | Class II | Active |
| Les Encres | DVAGP19120W-00170E | FDA UDI | Class II | Active |
| Les Encres | DVMXS29038C-60050X | FDA UDI | Class II | Active |
| Les Encres | DVSOP18100W-01160E | FDA UDI | Class II | Active |
| Les Encres | DVMXR29038C-60050X | FDA UDI | Class II | Active |
| Les Encres | DVAGP19100W-00160E | FDA UDI | Class II | Active |
| Les Encres | DVSRR18100W-02120X | FDA UDI | Class II | Active |
| Les Encres | DVMXB23050L-60070X | FDA UDI | Class II | Active |
| Les Encres | DVMXR27090C-50150X | FDA UDI | Class II | Active |
| Viola | DVMXR30025C-60030X | FDA UDI | Class II | Active |
| Les Encres | DVSRR18120W-02200X | FDA UDI | Class II | Active |
| Viola | DVSER19050L-02070X | FDA UDI | Class II | Active |
| Les Encres | DVSOR18100W-02170X | FDA UDI | Class II | Active |
| Les Encres | DVMXR29060C-60090X | FDA UDI | Class II | Active |
| Les Encres | DVMXS30038B-60040X | FDA UDI | Class II | Active |
| Les Encres | DVMXR27060C-50090X | FDA UDI | Class II | Active |
| Viola | K190264 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Meditime Co., Ltd Won Ju Gangwon · KR FEI 3016244792