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Disposable Powered Endoscopic Stapler
EUDAMEDClass IIa (EU MDR)
Ref BNJLModel BNJL-SA;BNJL-CA;BNJL-EA;BNJL-SC;BNJL-CC;BNJL-ECRef P440Model ELSP-60ERef P430Model ELSP-45E
Identity
- Trade Name
- Disposable Powered Endoscopic Stapler EUDAMED
- Device Name
- Disposable Powered Endoscopic Staplers EUDAMED
- Model / Reference
- BNJL-SA;BNJL-CA;BNJL-EA;BNJL-SC;BNJL-CC;BNJL-EC EUDAMEDBNJL EUDAMEDELSP-60E EUDAMEDP440 EUDAMEDELSP-45E EUDAMEDP430 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767872879 EUDAMED06971767871773 EUDAMED06971767873371 EUDAMED06971767871759 EUDAMED06971767873340 EUDAMED
- Basic UDI-DI
- 697176787BNJLET4 EUDAMED697176787P440NM EUDAMED697176787P430NJ 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 Powered 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 | 697176787BNJLET4 | 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 (5)
- EUDAMED 7f94d80a-caec-4528-8de9-ad2d1988f46d 61 fields · synced Jul 22, 2026
- EUDAMED c6b9f7e3-2773-4e60-9c55-138c69cabff0 61 fields · synced May 16, 2026
- EUDAMED ec831440-81dc-460a-8661-b26ff335d29d 61 fields · synced May 16, 2026
- EUDAMED 69d9da21-006e-4b78-9bbb-75fcfd4148cc 61 fields · synced May 18, 2026
- EUDAMED 4a05c198-6155-477a-99e3-f921d83f3664 61 fields · synced May 19, 2026