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Disposable Endoscopic Cutting Staplers and Reload
EUDAMEDClass IIb (EU MDR)
Ref GCJQW-45UModel GCJQW
Identity
- Trade Name
- Disposable Endoscopic Cutting Staplers and Reload EUDAMED
- Device Name
- Disposable Endoscopic Cutting Staplers and Reload EUDAMED
- Model / Reference
- GCJQW EUDAMEDGCJQW-45U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922798721247 EUDAMED
- Basic UDI-DI
- B-06922798721247 EUDAMED692279871004LB EUDAMED
- Direct Marketing DI
- 06922798721247 EUDAMED
- EMDN Code
- H020301040102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Endoscopic Cutting Staplers and Reload by Jiangsu Guanchuang Medical Technology Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06922798721247 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06922798721247 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangsu Guanchuang Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021127
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 56d28517-1266-49a4-a577-09b18cccdad4 61 fields · synced Oct 7, 2026
- EUDAMED b0622aab-30ce-476c-9d30-600e9795506e 61 fields · synced May 17, 2026