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Disposable Linear Staplers and Reload
EUDAMEDClass IIb (EU MDR)
Ref GCZFA-45LModel GCZFARef GCZFA-ZJ45LRef GCZFA-ZJ60HRef GCZFB-ZJ45HModel GCZFBRef GCZFB-45LRef GCZFB-ZJ45LRef GCZFA-30HRef GCZFB-ZJ60LRef GCZFB-30HRef GCZFB-45HRef GCZFA-45HRef GCZFB-60H
Identity
- Trade Name
- Disposable Linear Staplers and Reload EUDAMEDDisposable linear staplers and reload EUDAMED
- Device Name
- Disposable Linear Staplers and Reload EUDAMED
- Model / Reference
- GCZFA EUDAMEDGCZFA-45L EUDAMEDGCZFA-ZJ45L EUDAMEDGCZFA-ZJ60H EUDAMEDGCZFB EUDAMEDGCZFB-ZJ45H EUDAMEDGCZFB-45L EUDAMEDGCZFB-ZJ45L EUDAMEDGCZFA-30H EUDAMEDGCZFB-ZJ60L EUDAMEDGCZFB-30H EUDAMEDGCZFB-45H EUDAMEDGCZFA-45H EUDAMEDGCZFB-60H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922798712221 EUDAMED06922798714225 EUDAMED06922798714317 EUDAMED06922798715215 EUDAMED06922798713228 EUDAMED06922798715222 EUDAMED06922798712115 EUDAMED06922798715321 EUDAMED06922798713112 EUDAMED06922798713211 EUDAMED06922798712214 EUDAMED06922798713310 EUDAMED
- Basic UDI-DI
- B-06922798712221 EUDAMEDB-06922798714225 EUDAMEDB-06922798714317 EUDAMEDB-06922798715215 EUDAMEDB-06922798713228 EUDAMEDB-06922798715222 EUDAMEDB-06922798712115 EUDAMEDB-06922798715321 EUDAMEDB-06922798713112 EUDAMEDB-06922798713211 EUDAMEDB-06922798712214 EUDAMEDB-06922798713310 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
EUDAMEDEUDAMED
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-06922798712221 | 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 (12)
- EUDAMED 19ad8ea2-db89-4130-a375-926acf3ed1fe 61 fields · synced Oct 6, 2026
- EUDAMED 8774e7f1-865c-4fc8-88fe-52d77020aa0f 61 fields · synced May 11, 2026
- EUDAMED 392ff5d7-4f1a-4399-96ad-a52fbb1b636f 61 fields · synced May 16, 2026
- EUDAMED b14c1811-d430-4a25-90b0-b48c93619841 61 fields · synced May 17, 2026
- EUDAMED 165f537f-7acf-47cd-828e-84ed6efb541a 61 fields · synced May 17, 2026
- EUDAMED d48351b7-f987-4501-bde5-2d947f9f0ed6 61 fields · synced May 17, 2026
- EUDAMED 0247dcb7-4051-4ab1-adc1-2cff5b4b9edb 61 fields · synced May 17, 2026
- EUDAMED fb8dd8a3-7a91-4f61-a190-3567b3d0dcd9 61 fields · synced May 18, 2026
- EUDAMED 3bbef56e-17db-4028-bd60-816ff31b6c75 61 fields · synced May 18, 2026
- EUDAMED 3615cce8-7f41-4ebc-a897-e0fb8730d9cb 61 fields · synced May 18, 2026
- EUDAMED ab57bfa1-c9c9-40cf-9cf8-36f34827c7fc 61 fields · synced May 18, 2026
- EUDAMED 3df1b6a4-fc80-4022-9595-378bf34e7f4f 61 fields · synced May 18, 2026