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easyEndoTM Lite Linear Cutting Stapler for Single Use
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref U12S60Model U12S45; U12S60; U12M45; U12M60; U12L45; U12L60; U12S45X, U12S60X, U12M45X, U12M60X, U12L45X, U12L60X
Identity
- Trade Name
- easyEndoTM Lite Linear Cutting Stapler for Single Use EUDAMEDFDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Linear Cutting Staplers for Single Use EUDAMEDLite Linear Cutting Stapler, 260mm long, 12.3mm diameter FDA UDI
- Model / Reference
- U12S45; U12S60; U12M45; U12M60; U12L45; U12L60; U12S45X, U12S60X, U12M45X, U12M60X, U12L45X, U12L60X EUDAMEDU12S60 EUDAMEDFDA UDI
- Description
- Lite Linear Cutting Stapler, 260mm long, 12.3mm diameter FDA UDI
Identifiers
- Catalog Number
- U12S60 FDA UDI
- Primary DI / UDI-DI
- 06925776102601 EUDAMEDFDA UDI
- Basic UDI-DI
- 69257761000313XJ EUDAMED
- 510(k) Number
- K210909 FDA UDI
- FDA Product Code
- GAG FDA UDI
- EMDN Code
- H020201020101,H020301050201,H020301050202 EUDAMED
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4740 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
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
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69257761000313XJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 ac34d09c-7e8f-4ba0-ab24-a1cc716d3a9d 61 fields · synced Jun 6, 2026
- FDA UDI 0a2342b1-f19c-4284-9608-86e0b0801ad5 36 fields · synced May 30, 2026