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easyEndo™ Lite Loading Unit for Single Use
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref N60MTModel N45VM, N45MT, N60VM, N60MT, N45XT, N60XT Ref N45GModel N45M; N45W;N45B; N45C; N45G; N60M; N60W; N60B; N60C; N60GRef N45BRef N60WRef N60CCModel N45BC, N45CC, N45GC, N60BC, N60CC, N60GC Ref N60GRef N60BRef N60MRef N45CC
Identity
- Trade Name
- easyEndo™ Lite Loading Unit for Single Use EUDAMEDeasyEndoTM Lite Loading Unit for Single Use FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Loading Units for Single Use EUDAMEDLoading units for Single Use EUDAMEDLite Loading Unit, 45mm long, staple height 4.1mm, green FDA UDILite Loading Unit, 45mm long, staple height 3.5mm, blue FDA UDILite Loading Unit, 60mm long, staple height 2.5mm, white FDA UDILite Loading Unit, 60mm long, staple height 4.1mm, green FDA UDILite Loading Unit, 60mm long, staple height 3.5mm, blue FDA UDILite Loading Unit, 60mm long, staple height 2.0mm, grey FDA UDI
- Model / Reference
- N45VM, N45MT, N60VM, N60MT, N45XT, N60XT EUDAMEDN60MT EUDAMEDN45M; N45W;N45B; N45C; N45G; N60M; N60W; N60B; N60C; N60G EUDAMEDN45G EUDAMEDFDA UDIN45B EUDAMEDFDA UDIN60W EUDAMEDFDA UDIN45BC, N45CC, N45GC, N60BC, N60CC, N60GC EUDAMEDN60CC EUDAMEDN60G EUDAMEDFDA UDIN60B EUDAMEDFDA UDIN60M EUDAMEDFDA UDIN45CC EUDAMED
- Description
- Lite Loading Unit, 45mm long, staple height 4.1mm, green FDA UDILite Loading Unit, 45mm long, staple height 3.5mm, blue FDA UDILite Loading Unit, 60mm long, staple height 2.5mm, white FDA UDILite Loading Unit, 60mm long, staple height 4.1mm, green FDA UDILite Loading Unit, 60mm long, staple height 3.5mm, blue FDA UDILite Loading Unit, 60mm long, staple height 2.0mm, grey FDA UDI
Identifiers
- Catalog Number
- N45G FDA UDIN45B FDA UDIN60W FDA UDIN60G FDA UDIN60B FDA UDIN60M FDA UDI
- Primary DI / UDI-DI
- 06925776105091 EUDAMED06925776102489 EUDAMEDFDA UDI06925776102465 EUDAMEDFDA UDI06925776102502 EUDAMEDFDA UDI06925776105046 EUDAMED06925776102533 EUDAMEDFDA UDI06925776102519 EUDAMEDFDA UDI06925776102496 EUDAMEDFDA UDI06925776105015 EUDAMED
- Basic UDI-DI
- 69257761000303XF EUDAMED69257761000301XB EUDAMED69257761000302XD EUDAMED
- 510(k) Number
- K210909 FDA UDI
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H0202010302,H02030106 EUDAMED
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- France EUDAMEDGermany EUDAMED
- 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
Sutures
Yes
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
MR Conditional FDA UDI
easyEndo™ Lite Loading Unit for Single Use by Ezisurg Medical Co., Ltd. — Class IIb — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69257761000303XF | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ezisurg Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000006742
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (21)
- EUDAMED 54cdc3c6-f4e3-4bd3-98ca-d80df855878e 61 fields · synced Sep 18, 2026
- EUDAMED 460b56d6-768b-4c96-910e-a17b9f8b1353 61 fields · synced May 16, 2026
- EUDAMED 3a605a80-aa88-48a0-ae9c-52d107bd5fb4 61 fields · synced May 16, 2026
- EUDAMED e339e9e8-0f72-4de4-b88a-d5745d489262 61 fields · synced May 17, 2026
- EUDAMED 43940da7-ae24-4f23-908d-3fcbcb785534 61 fields · synced May 17, 2026
- EUDAMED 03329978-e66f-4228-af1a-862209865c37 61 fields · synced May 17, 2026
- EUDAMED 23e0cc8b-708d-448a-91b1-40008cc6b97f 61 fields · synced May 18, 2026
- FDA UDI 99d63aa1-2e3f-4cca-b9ee-ef4f2d3722da 36 fields · synced May 27, 2026
- FDA UDI 23fb7a13-6c1c-422c-b00d-52d5f9aa7ede 36 fields · synced May 30, 2026
- FDA UDI ef853c87-45c5-4b3f-ad1d-462081375a28 36 fields · synced May 30, 2026
- FDA UDI 83ac44d0-b82c-47b4-85e8-8dcabcbc7479 36 fields · synced May 30, 2026
- FDA UDI 65794acf-1c84-4b28-a749-163088f4e0c9 36 fields · synced May 30, 2026
- FDA UDI b546d053-d52a-457d-9a9d-30ca5b123c0c 36 fields · synced May 30, 2026
- EUDAMED 2ddecaac-f54e-4832-a6d8-74f1a458680c 61 fields · synced Jul 10, 2026
- EUDAMED 188dd442-4227-48e4-8a45-0420ff418da4 61 fields · synced Jul 10, 2026
- EUDAMED b4f791bc-90fb-442b-8ff6-4a4f6d77b60b 61 fields · synced Jul 15, 2026
- EUDAMED 124e20f4-4e4d-4a54-9a48-f1498ef9a19f 61 fields · synced Jul 15, 2026
- EUDAMED 7a2075c8-3ce2-417c-9d96-9de508dd4fd0 61 fields · synced Jul 18, 2026
- EUDAMED 556b4d26-f76e-4503-b142-d08c90ce1eb6 61 fields · synced Jul 28, 2026
- EUDAMED 6573676c-cf68-474d-973d-e317e3c9e26f 61 fields · synced Aug 2, 2026
- EUDAMED f8218504-1632-4b71-86ab-ffd1b65df100 61 fields · synced Sep 18, 2026