← Back to catalogue
FHY series of disposable linear stapler and cartridge
EUDAMEDClass IIb (EU MDR)
Ref 12002045Model FZ-45-D
Identity
- Trade Name
- FHY series of disposable linear stapler and cartridge EUDAMED
- Device Name
- FHY series of disposable linear stapler and cartridge EUDAMED
- Model / Reference
- FZ-45-D EUDAMED12002045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936594493000 EUDAMED
- Basic UDI-DI
- B-06936594493000 EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Category: Open-surgery manual linear cutting stapler, single-use
FHY series of disposable linear stapler and cartridge by Changzhou Waston Medical Appliance Co., Ltd — Class IIb — MDD — listed in EUDAMED
Similar devices
Also classified as Open-surgery manual linear cutting stapler, single-use.
- GIA — Covidien LP · Class II
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- Disposable Circumcision Staplers — Sinolinks Medical Innovation, Inc. · Class IIa
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Disposable Endoscopic Linear Cutter Staplers and Cartridges — ChangZhou 3R Medical Device Technology Co.,Ltd · Class IIb
- Disposable Foreskin Stapler — Jiangsu Celtics MediTech Co.,Ltd. · Class IIa
- Disposable Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation, Inc. · Class IIb
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-06936594493000 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Waston Medical Appliance Co., Ltd
- EUDAMED SRN
- CN-MF-000004851
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b67710ab-d893-4b59-b85a-8368e7b38c9c 61 fields · synced Jul 22, 2026