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Disposable Circular Staplers for Hemorrhoids
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref GCGZA-34Model GCGZA510(k) K161905
Identity
- Trade Name
- Disposable Circular Staplers for Hemorrhoids EUDAMED
- Device Name
- Disposable Circular Staplers for Hemorrhoids EUDAMED
- Model / Reference
- GCGZA EUDAMEDGCGZA-34 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922798711200 EUDAMED
- Basic UDI-DI
- B-06922798711200 EUDAMED
- EMDN Code
- H02020299 CIRCULAR STAPLERS FOR OPEN SURGERY - OTHER 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
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 Circular Staplers for Hemorrhoids by Jiangsu Guanchuang Medical Technology Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161905 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06922798711200 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangsu Guanchuang Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021127
- FDA Applicant
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 0257a4ee-2833-4081-b4ab-5ef865ec5686 85 fields · synced Jun 18, 2026
- FDA 510(k) K161905 1 fields · synced May 18, 2026