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Disposable Endoscopic Stapler
EUDAMEDClass IIa (EU MDR)
Ref ELSModel ELS12-S,ELS15-S,ELS12-C,ELS15-C,ELS12-E,ELS15-E,ELSC-S,ELSC-C,ELSC-E,ELST-S,ELST-C,ELST-E,ELSJ-S,ELSJ-C,ELSJ-E
Identity
- Trade Name
- Disposable Endoscopic Stapler EUDAMED
- Device Name
- Disposable Endoscopic Staplers EUDAMED
- Model / Reference
- ELS12-S,ELS15-S,ELS12-C,ELS15-C,ELS12-E,ELS15-E,ELSC-S,ELSC-C,ELSC-E,ELST-S,ELST-C,ELST-E,ELSJ-S,ELSJ-C,ELSJ-E EUDAMEDELS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767872022 EUDAMED
- Basic UDI-DI
- 697176787ELSXB EUDAMED
- EMDN Code
- H020201010101,H020301040199 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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
Disposable Endoscopic Stapler by Wuxi Beien Surgery Device 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 | 697176787ELSXB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wuxi Beien Surgery Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000017684
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 94eb66f2-03a0-49c0-a26a-db3db1a5d807 61 fields · synced May 23, 2026