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Disposable Endoscopic Stapler Reload Unit
EUDAMEDClass IIb (EU MDR)
Ref MANUALRef 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-ERef ELSQModel ELSQ-45S,ELSQ-45C,ELSQ-45E,ELSQ-60S,ELSQ-60C,ELSQ-60E
Identity
- Trade Name
- Disposable Endoscopic Stapler Reload Unit EUDAMEDDisposable Endoscopic Stapler EUDAMED
- Device Name
- Disposable Endoscopic Stapler Reload Units EUDAMEDDisposable Endoscopic Staplers EUDAMED
- Model / Reference
- MANUAL EUDAMEDELS12-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 EUDAMEDELSQ-45S,ELSQ-45C,ELSQ-45E,ELSQ-60S,ELSQ-60C,ELSQ-60E EUDAMEDELSQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767870707 EUDAMED06971767872640 EUDAMED06971767870608 EUDAMED06971767871285 EUDAMED06971767871070 EUDAMED06971767871049 EUDAMED06971767871674 EUDAMED06971767872008 EUDAMED06971767870691 EUDAMED06971767872688 EUDAMED06971767872527 EUDAMED06971767870561 EUDAMED06971767876495 EUDAMED06971767872039 EUDAMED06971767871582 EUDAMED06971767870387 EUDAMED06971767870981 EUDAMED06971767871391 EUDAMED06971767870752 EUDAMED06971767871209 EUDAMED06971767870813 EUDAMED06971767870516 EUDAMED06971767870035 EUDAMED06971767870905 EUDAMED06971767872558 EUDAMED06971767870110 EUDAMED06971767871698 EUDAMED06971767870301 EUDAMED06971767871513 EUDAMED06971767872664 EUDAMED06971767872077 EUDAMED06971767871551 EUDAMED06971767871728 EUDAMED06971767872237 EUDAMED06971767871155 EUDAMED06971767872107 EUDAMED06971767871681 EUDAMED06971767872190 EUDAMED06971767872213 EUDAMED06971767870851 EUDAMED06971767870721 EUDAMED06971767870325 EUDAMED06971767872671 EUDAMED06971767872572 EUDAMED06971767874491 EUDAMED06971767871667 EUDAMED06971767870530 EUDAMED06971767870073 EUDAMED06971767870998 EUDAMED06971767870790 EUDAMED06971767871490 EUDAMED06971767870097 EUDAMED06971767871308 EUDAMED06971767874354 EUDAMED06971767870059 EUDAMED06971767870356 EUDAMED06971767870868 EUDAMED06971767872633 EUDAMED06971767872152 EUDAMED06971767872268 EUDAMED06971767871568 EUDAMED06971767871544 EUDAMED06971767872176 EUDAMED06971767870554 EUDAMED06971767870677 EUDAMED06971767871520 EUDAMED06971767870318 EUDAMED06971767876365 EUDAMED06971767870066 EUDAMED06971767871643 EUDAMED06971767871650 EUDAMED06971767874187 EUDAMED06971767872251 EUDAMED06971767876358 EUDAMED06971767871605 EUDAMED06971767870950 EUDAMED06971767874361 EUDAMED06971767871322 EUDAMED06971767870660 EUDAMED06971767870523 EUDAMED06971767876259 EUDAMED06971767872015 EUDAMED06971767872565 EUDAMED06971767871339 EUDAMED06971767870363 EUDAMED06971767870912 EUDAMED06971767874255 EUDAMED06971767874484 EUDAMED06971767871636 EUDAMED
- Basic UDI-DI
- 69717687MANUAL4K EUDAMED697176787ELSXB EUDAMED697176787ELSQUM EUDAMED
- EMDN Code
- H020201010101,H020301040199 EUDAMEDH020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass 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 Reload Unit by Wuxi Beien Surgery Device Co., Ltd. — Class IIb — 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 | 69717687MANUAL4K | Class IIb | 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 (89)
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