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easyEndoTM Lite Linear Cutting Stapler for Single Use

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref U12L60Model U12S45; U12S60; U12M45; U12M60; U12L45; U12L60; U12S45X, U12S60X, U12M45X, U12M60X, U12L45X, U12L60XRef F12M45XGModel F12M45G; F12M60G; F12M45XG, F12M60XG Ref U12S45Ref U12M60XGModel U12S45G; U12S60G; U12M45G; U12M60G; U12L45G; U12L60G, U12S45XG, U12S60XG, U12M45XG, U12M60XG, U12L45XG, U12L60XGRef U12L45XGRef F12M60GRef F12M60XModel F12M45; F12M60; F12M45X, F12M60XRef U12L45Ref U12S45XGRef U12S60GRef U12M60Ref F12M60Ref U12S60XRef F12M60XGRef U12M45XRef F12M45XRef F12M60XG Ref U12L60GRef U12S45XRef F12M45XG Ref U12S60XGRef U12S45GRef U12L60X

by Ezisurg Medical Co., Ltd

Identity

Trade Name
easyEndoTM Lite Linear Cutting Stapler for Single Use EUDAMEDFDA UDI
easyEndo™ Lite Linear Cutting Stapler for Single Use EUDAMED
easyEndo™ Lite Linear Cutting Stapler for Single Use EUDAMED
Generic Name
Endoscopic manual linear cutting stapler, single-use FDA UDI
Device Name
Linear Cutting Staplers for Single Use EUDAMED
Linear Cutting Staplers for Single Use EUDAMED
Lite Linear Cutting Stapler, 350mm long, 12.3mm diameter FDA UDI
Lite Linear Cutting Stapler, 440mm long, 12.3mm diameter FDA UDI
Lite Linear Cutting Stapler, 260mm long, 12.3mm diameter FDA UDI
Model / Reference
U12S45; U12S60; U12M45; U12M60; U12L45; U12L60; U12S45X, U12S60X, U12M45X, U12M60X, U12L45X, U12L60X EUDAMED
U12L60 EUDAMEDFDA UDI
F12M45G; F12M60G; F12M45XG, F12M60XG EUDAMED
F12M45XG EUDAMED
U12S45 EUDAMEDFDA UDI
U12S45G; U12S60G; U12M45G; U12M60G; U12L45G; U12L60G, U12S45XG, U12S60XG, U12M45XG, U12M60XG, U12L45XG, U12L60XG EUDAMED
U12M60XG EUDAMED
U12L45XG EUDAMED
F12M60G EUDAMED
F12M45; F12M60; F12M45X, F12M60X EUDAMED
F12M60X EUDAMED
U12L45 EUDAMEDFDA UDI
U12S45XG EUDAMED
U12S60G EUDAMED
U12M60 EUDAMEDFDA UDI
F12M60 EUDAMED
U12S60X EUDAMED
F12M60XG EUDAMED
U12M45X EUDAMED
F12M45X EUDAMED
U12L60G EUDAMED
U12S45X EUDAMED
U12S60XG EUDAMED
U12S45G EUDAMED
U12L60X EUDAMED
Description
Lite Linear Cutting Stapler, 350mm long, 12.3mm diameter FDA UDI
Lite Linear Cutting Stapler, 440mm long, 12.3mm diameter FDA UDI
Lite Linear Cutting Stapler, 260mm long, 12.3mm diameter FDA UDI

Identifiers

Catalog Number
U12M60 FDA UDI
U12L60 FDA UDI
U12L45 FDA UDI
U12S45 FDA UDI
Primary DI / UDI-DI
06925776102540 EUDAMEDFDA UDI
06925776118091 EUDAMED
06925776102571 EUDAMEDFDA UDI
06925776118145 EUDAMED
06925776118152 EUDAMED
06925776118022 EUDAMED
06925776103493 EUDAMED
06925776102595 EUDAMEDFDA UDI
06925776118114 EUDAMED
06925776118046 EUDAMED
06925776102618 EUDAMEDFDA UDI
06925776102564 EUDAMED
06925776105312 EUDAMED
06925776118107 EUDAMED
06925776105329 EUDAMED
06925776103486 EUDAMED
06925776118084 EUDAMED
06925776105305 EUDAMED
06925776118121 EUDAMED
06925776118039 EUDAMED
06925776105350 EUDAMED
Basic UDI-DI
69257761000313XJ EUDAMED
69257761000312XG EUDAMED
69257761000314XL EUDAMED
69257761000311XE EUDAMED
510(k) Number
K210909 FDA UDI
FDA Product Code
GAG FDA UDI
EMDN Code
H020201020101,H020301050201,H020301050202 EUDAMED
H020201010102,H020301040201,H020301040202 EUDAMED
H020201020201,H020301050101,H020301050102 EUDAMED
H020201010101,H020301040101,H020301040102 EUDAMED
GMDN Term
Endoscopic manual linear cutting stapler, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
878.4740 FDA UDI
Market of Registration
France EUDAMED
Germany 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

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

easyEndoTM Lite Linear Cutting Stapler for Single Use by Ezisurg Medical Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ezisurg Medical Co., Ltd
EUDAMED SRN
CN-MF-000006742
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (41)

  • EUDAMED 197d8ff9-f18c-4082-b948-fd7a0382919a 61 fields · synced Sep 18, 2026
  • EUDAMED 8aafe4c3-a573-4cbe-b245-a797e299cadb 61 fields · synced May 16, 2026
  • EUDAMED 0810dc90-3d5f-4c59-87ca-49f988711018 61 fields · synced May 16, 2026
  • EUDAMED 0b3da13c-75c6-4386-a9b9-15344002516a 61 fields · synced May 17, 2026
  • EUDAMED 1cbe09dc-68e9-40b6-bb7d-08723216cba3 61 fields · synced May 17, 2026
  • EUDAMED 9691118c-c8ac-4d6a-9281-52be92ac107f 61 fields · synced May 17, 2026
  • EUDAMED ccbda9d9-beba-46b7-a9d0-cf19f730d7b4 61 fields · synced May 17, 2026
  • EUDAMED 72502f80-5677-45b4-8713-71e3c8a3c126 61 fields · synced May 17, 2026
  • EUDAMED 1e47d1a1-c9b2-4faa-9ce4-d293e0365162 61 fields · synced May 17, 2026
  • EUDAMED cf391f2a-616f-41f2-9aae-3ff8c1bc107c 61 fields · synced May 18, 2026
  • EUDAMED 58d47517-022f-4acd-a3b5-c9b5e7affba4 61 fields · synced May 18, 2026
  • EUDAMED 7f5dd965-e896-4577-9747-b54cf5c3101c 61 fields · synced May 18, 2026
  • EUDAMED 3d229c63-bce8-43ca-9938-a116b1444f10 61 fields · synced May 18, 2026
  • EUDAMED e4fc2667-33fe-48f8-ae55-7687f08349fc 61 fields · synced May 18, 2026
  • EUDAMED f777e410-94b5-4cd7-b658-66c8617e5698 61 fields · synced May 18, 2026
  • EUDAMED 8e297848-402b-4baa-a73e-5d7873ff6cf3 61 fields · synced May 18, 2026
  • FDA UDI b73015d3-14f2-4cb0-a7bf-3f24bc0fc386 36 fields · synced May 30, 2026
  • FDA UDI 33212a8f-df25-4387-bdb2-df1bf7781b18 36 fields · synced May 30, 2026
  • FDA UDI 4dcae8c6-f07f-49e1-8c87-385dea5e58b4 36 fields · synced May 30, 2026
  • FDA UDI ba8672a9-b574-4712-a062-cdfa74eca616 36 fields · synced May 30, 2026
  • EUDAMED 760c60cc-d6d5-43f5-a2ee-fb48331967cd 61 fields · synced Jun 20, 2026
  • EUDAMED 595230ba-7379-4cff-80cb-10b554f965f3 61 fields · synced Jul 8, 2026
  • EUDAMED 8c426f00-f119-4fe1-9525-8771b920fe36 61 fields · synced Jul 9, 2026
  • EUDAMED 0af70800-b294-4587-9ca2-54e9555a8063 61 fields · synced Jul 11, 2026
  • EUDAMED ebc51575-b039-45c0-b325-7d00ea32d4e4 61 fields · synced Jul 13, 2026
  • EUDAMED f810c51e-d34d-4f3f-ad57-aef1631c8914 61 fields · synced Jul 16, 2026
  • EUDAMED 6f8d5d12-1132-4187-85ae-df435127fd22 61 fields · synced Jul 17, 2026
  • EUDAMED f3bd2ad7-046b-4e6f-b508-b3e25cf4e6ce 61 fields · synced Jul 20, 2026
  • EUDAMED d90d54f7-062d-4876-bb8f-c9a3ad1de11d 61 fields · synced Jul 21, 2026
  • EUDAMED d48ca2a0-0f66-4528-af4c-df87daa9594b 61 fields · synced Jul 23, 2026
  • EUDAMED 8c9b3b84-e070-4e3e-8c0d-2b2ea52fba8a 61 fields · synced Jul 25, 2026
  • EUDAMED 3c2327c6-e618-4713-9fcf-886cfc6d7cb9 61 fields · synced Jul 25, 2026
  • EUDAMED bfcd8015-89b9-401e-bb68-0e71329e7dde 61 fields · synced Jul 28, 2026
  • EUDAMED 811147ea-28e2-45e0-87fd-c9e79ea3d079 61 fields · synced Jul 28, 2026
  • EUDAMED f40e3d3a-66db-4c63-a1bb-eb6db7beacd9 61 fields · synced Jul 29, 2026
  • EUDAMED c2a1563f-08b0-46fe-892c-6f5235fa9d2b 61 fields · synced Jul 29, 2026
  • EUDAMED a357a6a1-6bfa-424f-9e29-421c1624e017 61 fields · synced Jul 31, 2026
  • EUDAMED e7503d40-8632-4bed-af91-5b06eb54bd95 61 fields · synced Aug 1, 2026
  • EUDAMED b87951de-1d54-431b-abc2-ba68dc56e784 61 fields · synced Aug 3, 2026
  • EUDAMED 695462de-0049-4d7f-8b08-8e3bd6e93c19 61 fields · synced Aug 4, 2026
  • EUDAMED b28d81bf-b84b-486b-b09c-61cb62d46c83 61 fields · synced Sep 18, 2026