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Unimide

EUDAMEDFDA UDIFDA 510(k)

Class III (EU MDR)

Ref DW3261RModel UNIMIDE

by United Medical Industries Co. Ltd

Identity

Trade Name
UNIMIDE EUDAMEDFDA UDI
Generic Name
Nylon suture, non-bioabsorbable, monofilament FDA UDI
Device Name
Sterile Single Use Synthetic Non-Absorbable Surgical Suture with or without needle EUDAMED
Monofilament, Polyamide, Synthetic, Non-absorbable Surgical Sututres / Ligatures FDA UDI
Model / Reference
UNIMIDE EUDAMED
DW3261R EUDAMEDFDA UDI
Description
Monofilament, Polyamide, Synthetic, Non-absorbable Surgical Sututres / Ligatures FDA UDI

Identifiers

Catalog Number
DW3261R FDA UDI
Primary DI / UDI-DI
06285379050779 EUDAMED
16285379148893 FDA UDI
Basic UDI-DI
B-06285379050779 EUDAMED
510(k) Number
K042284 FDA UDI
FDA Product Code
GAR FDA UDI
EMDN Code
H010201010101,H010201010102 EUDAMED
GMDN Term
Nylon suture, non-bioabsorbable, monofilament FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
878.5020 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 — 0.15 Millimeter FDA UDI

Unimide 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

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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 d34d9603-4750-4b89-a604-9862e78ff968 61 fields · synced Jul 11, 2026
  • FDA UDI ae38bcb2-1c01-4143-a1b9-cad025b19483 38 fields · synced May 30, 2026
  • FDA 510(k) K042284 1 fields · synced May 18, 2026