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Cys
EUDAMEDClass IIa (EU MDR)
Ref PF0025K/CSPF-25KModel CSPF-15W CSPF-25W CSPF-35W CSPF-15R CSPF-25R CSPF-35R etc
Identity
- Trade Name
- CYS EUDAMED
- Device Name
- Disposable Skin Stapler EUDAMED
- Model / Reference
- CSPF-15W CSPF-25W CSPF-35W CSPF-15R CSPF-25R CSPF-35R etc EUDAMEDPF0025K/CSPF-25K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956862070108 EUDAMED
- Basic UDI-DI
- 69568620PFJN EUDAMED
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cys by Changzhou Medical Bioengineering Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69568620PFJN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Medical Bioengineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026604
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3a676304-372e-49d0-9838-44fd725de9c6 61 fields · synced Jun 17, 2026