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FHY series of disposable linear stapler and cartridge
EUDAMEDClass IIb (EU MDR)
Ref 12002060Model FZ-60-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-60-D EUDAMED12002060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936594498203 EUDAMED
- Basic UDI-DI
- B-06936594498203 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
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Also classified as Open-surgery manual linear cutting stapler, single-use.
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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-06936594498203 | Class IIb | Active |
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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 5bef6abb-2320-43cf-af11-6591eeef1797 61 fields · synced Jun 19, 2026