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Disposable Linear Staplers and Reload
EUDAMEDClass IIb (EU MDR)
Ref GCZFB-60LModel GCZFB
Identity
- Trade Name
- Disposable Linear Staplers and Reload EUDAMED
- Device Name
- Disposable Linear Staplers and Reload EUDAMED
- Model / Reference
- GCZFB EUDAMEDGCZFB-60L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922798713327 EUDAMED
- Basic UDI-DI
- B-06922798713327 EUDAMED
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY 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 Linear Staplers and Reload by Jiangsu Guanchuang Medical Technology 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-06922798713327 | 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 (1)
- EUDAMED 5452c8c5-e1b6-4493-a842-d9342b105a64 61 fields · synced Oct 7, 2026