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Unicaprone
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref DW13902RUModel UNICAPRONE
Identity
- Trade Name
- UNICAPRONE EUDAMEDFDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- Sterile Single Use Synthetic Absorbable Surgical Suture with or without needle EUDAMEDMonofilament Polyglecaprone 25 Synthetic Absorbable Surgical Sututres / Ligatures FDA UDI
- Model / Reference
- UNICAPRONE EUDAMEDDW13902RU EUDAMEDFDA UDI
- Description
- Monofilament Polyglecaprone 25 Synthetic Absorbable Surgical Sututres / Ligatures FDA UDI
Identifiers
- Catalog Number
- DW13902RU FDA UDI
- Primary DI / UDI-DI
- 06285379008268 EUDAMED16285379148855 FDA UDI
- Basic UDI-DI
- B-06285379008268 EUDAMED
- 510(k) Number
- K072646 FDA UDI
- FDA Product Code
- GAM FDA UDI
- EMDN Code
- H010101010301,H010101010302 EUDAMED
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4493 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.2 Millimeter FDA UDI
Unicaprone by United Medical Industries Co. Ltd — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072646 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06285379008268 | Class III | Active |
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Manufacturer
- Manufacturer
- United Medical Industries Co. Ltd
- EUDAMED SRN
- SA-MF-000004541
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 469d9ea3-8709-47f8-89aa-3a05214fbe29 61 fields · synced Jun 20, 2026
- FDA UDI e2227c4d-2e16-4f2d-acf1-8fa6bef909a1 38 fields · synced May 30, 2026
- FDA 510(k) K072646 1 fields · synced May 18, 2026