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Disposable Linear Cutter Stapler Reload Unit
EUDAMEDClass IIb (EU MDR)
Ref 60ZAModel ZQ60WRef 60ZCModel ZQ60GRef 80ZBModel ZQ80BRef 8045EModel GCA80Ref 100ZBModel ZQ100BRef 100ZAModel ZQ100WRef 80ZCModel ZQ80GRef 80ZAModel ZQ80WRef 100ZCModel ZQ100GRef 10038EModel BCA100Ref 10025EModel WCA100Ref 8025EModel WCA80Ref 10045EModel GCA100
Identity
- Trade Name
- Disposable Linear Cutter Stapler Reload Unit EUDAMED
- Device Name
- Disposable Linear Cutter Staplers EUDAMED
- Model / Reference
- ZQ60W EUDAMED60ZA EUDAMEDZQ60G EUDAMED60ZC EUDAMEDZQ80B EUDAMED80ZB EUDAMEDGCA80 EUDAMED8045E EUDAMEDZQ100B EUDAMED100ZB EUDAMEDZQ100W EUDAMED100ZA EUDAMEDZQ80G EUDAMED80ZC EUDAMEDZQ80W EUDAMED80ZA EUDAMEDZQ100G EUDAMED100ZC EUDAMEDBCA100 EUDAMED10038E EUDAMEDWCA100 EUDAMED10025E EUDAMEDWCA80 EUDAMED8025E EUDAMEDGCA100 EUDAMED10045E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767871445 EUDAMED06971767870486 EUDAMED06971767870493 EUDAMED06971767878048 EUDAMED06971767870646 EUDAMED06971767871469 EUDAMED06971767870547 EUDAMED06971767871452 EUDAMED06971767870684 EUDAMED06971767871025 EUDAMED06971767870189 EUDAMED06971767870172 EUDAMED06971767871032 EUDAMED
- Basic UDI-DI
- B-06971767871445 EUDAMEDB-06971767870486 EUDAMEDB-06971767870493 EUDAMEDB-06971767878048 EUDAMEDB-06971767870646 EUDAMEDB-06971767871469 EUDAMEDB-06971767870547 EUDAMEDB-06971767871452 EUDAMEDB-06971767870684 EUDAMEDB-06971767871025 EUDAMEDB-06971767870189 EUDAMEDB-06971767870172 EUDAMEDB-06971767871032 EUDAMED
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMEDH0202010301 SINGLE-PATIENT LINEAR SUTURE CARTDRIGES WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Linear Cutter Stapler Reload Unit by Wuxi Beien Surgery Device Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971767871445 | 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 (13)
- EUDAMED 5b0ac29a-3cae-4645-a85a-f3669a2801bf 61 fields · synced Aug 3, 2026
- EUDAMED 4a3b202a-d88c-49ce-930a-b614d4f27136 61 fields · synced May 16, 2026
- EUDAMED cccf8d7b-dc41-4aab-85a7-2ba91c8330de 61 fields · synced May 17, 2026
- EUDAMED af911995-9457-4031-9a12-c510a04a3d07 61 fields · synced May 17, 2026
- EUDAMED b32ce45a-315a-4e91-a52b-514cc3df4a91 61 fields · synced May 17, 2026
- EUDAMED 3886d7d1-382c-4ec1-85fb-1d1270e262bb 61 fields · synced May 18, 2026
- EUDAMED 0ff758cc-79ea-44ed-8efc-5e8217296bbf 61 fields · synced May 18, 2026
- EUDAMED dceebb88-7e9d-4f7d-9e4a-2b7485b89031 61 fields · synced May 18, 2026
- EUDAMED bb46499d-1859-44bf-a57c-df3025199c65 61 fields · synced May 18, 2026
- EUDAMED a62c16ac-bb61-4c8c-9794-1ceab353f332 61 fields · synced May 18, 2026
- EUDAMED fb54829b-89bc-4a0d-b17d-b923b1154154 61 fields · synced May 18, 2026
- EUDAMED 621f6d84-e79c-493f-acfd-81795b45773b 61 fields · synced Jul 8, 2026
- EUDAMED 3b8386f1-e73c-4a61-9c9f-68b15a7b4e57 61 fields · synced Jul 10, 2026