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Endoscopic Instrument - Grasper

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref DI-5670-45DModel DI Series

by Lagis Enterprise Co., Ltd.

Identity

Trade Name
Endoscopic Instrument - Grasper EUDAMED
LAGIS FDA UDI
Generic Name
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Device Name
Endoscopic Instruments - Grasper EUDAMED
5mm x 450 mm Endo-Clinch Grasping Forceps, Double Action FDA UDI
Model / Reference
DI Series EUDAMED
DI-5670-45D EUDAMEDFDA UDI
Description
5mm x 450 mm Endo-Clinch Grasping Forceps, Double Action FDA UDI

Identifiers

Catalog Number
DI-5670-45D FDA UDI
Primary DI / UDI-DI
04714123022424 EUDAMEDFDA UDI
Basic UDI-DI
471412302DI-02QB EUDAMED
FDA Product Code
GCJ FDA UDI
EMDN Code
K01020104 MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE EUDAMED
GMDN Term
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Endoscopic Instrument - Grasper by Lagis Enterprise Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
TW-MF-000007081
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (2)

  • EUDAMED 1c6ef3f7-c6fb-4d55-a89b-e30c8a23ecad 61 fields · synced Jun 6, 2026
  • FDA UDI 0f63d556-3052-402f-939b-b341780486e0 35 fields · synced May 30, 2026