Identity
- Device Name
- Disposable Linear Staplers and Reloads EUDAMED
- Model / Reference
- SF453 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949298933031 EUDAMED
- Basic UDI-DI
- B-06949298933031 EUDAMED
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
The Disposable Linear Staplers and Reloads are a high-quality, disposable medical device designed for use in various medical specialties. These staplers feature advanced technology that enables precise and efficient stitching of surgical skin grafts, reducing the risk of complications. The device is manufactured by Jiangsu Brightness Medical Devices Co., Ltd., a reputable company with a strong track record of producing high-quality medical products.
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-06949298933031 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangsu Brightness Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000019184
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 896377ad-619a-49e4-abf0-3097e02adfd2 61 fields · synced Jul 25, 2026