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easyEndo™ Lite Loading Unit for Single Use
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref N45MModel N45M; N45W;N45B; N45C; N45G; N60M; N60W; N60B; N60C; N60G
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 EUDAMEDLite Loading Unit, 45mm long, staple height 2.0mm, grey FDA UDI
- Model / Reference
- N45M; N45W;N45B; N45C; N45G; N60M; N60W; N60B; N60C; N60G EUDAMEDN45M EUDAMEDFDA UDI
- Description
- Lite Loading Unit, 45mm long, staple height 2.0mm, grey FDA UDI
Identifiers
- Catalog Number
- N45M FDA UDI
- Primary DI / UDI-DI
- 06925776102441 EUDAMEDFDA UDI
- Basic UDI-DI
- 69257761000301XB 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 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 | 69257761000301XB | 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 (2)
- EUDAMED bdca3fc8-5d66-4a6c-8560-b7ae8adbf495 61 fields · synced Jun 6, 2026
- FDA UDI 1ab916da-9ff9-4450-bbbd-ec2d0a0adfbf 36 fields · synced May 30, 2026