Single Use Powered Endoscopic Linear Cutter Stapler

by Suzhou Frankenman Medical Equipment Co., Ltd China EUDAMED

Ref FP ELCB50

EMDN H020301040202

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69338168FPELC1TX Basic UDI-DI	Date13 Nov 2024Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: FP ELCB50

Primary DI / UDI-DI: 06933816809274
Basic UDI-DI: 69338168FPELC1TX, 69338168FPELCBUX
EMDN Code: H020301040202 Single patient straight linear staplers without blade for laparoscopy

Device Class: Class IIa
Market of Registration: Italy

Manufacturer details

EUDAMED SRN: CN-MF-000012943
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Single Use Reloadable Linear Stapler and Reloads

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Single Use Endoscopic Linear Cutter Stapler and Reloads

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See all devices from Suzhou Frankenman Medical Equipment Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (2)

EUDAMED 5d24d8f2-c636-4285-b039-2a3d3a1704d2 61 fields · synced 22 Oct 2026
EUDAMED 06933816809274|69338168FPELCBUX 61 fields · synced 7 Oct 2026