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easyEndoTM Lite Linear Cutting Stapler for Single Use
EUDAMEDClass IIa (EU MDR)
Ref U12M60XModel U12S45; U12S60; U12M45; U12M60; U12L45; U12L60; U12S45X, U12S60X, U12M45X, U12M60X, U12L45X, U12L60X
Identity
- Trade Name
- easyEndoTM Lite Linear Cutting Stapler for Single Use EUDAMED
- Device Name
- Linear Cutting Staplers for Single Use EUDAMED
- Model / Reference
- U12S45; U12S60; U12M45; U12M60; U12L45; U12L60; U12S45X, U12S60X, U12M45X, U12M60X, U12L45X, U12L60X EUDAMEDU12M60X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925776105336 EUDAMED
- Basic UDI-DI
- 69257761000313XJ EUDAMED
- EMDN Code
- H020201020101,H020301050201,H020301050202 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
easyEndoTM Lite Linear Cutting Stapler for Single Use by Ezisurg Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69257761000313XJ | Class IIa | Active |
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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 (1)
- EUDAMED 42e79cb6-3c08-441b-905d-c94ca943fbe0 61 fields · synced May 29, 2026