Identity
- Device Name
- Single Use Purse-String Instruments EUDAMED
- Model / Reference
- SPSI65 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948710441208 EUDAMED
- Basic UDI-DI
- B-06948710441208 EUDAMED
- EMDN Code
- H020299 STAPLERS FOR OPEN SURGERY - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Single Use Purse-String Instruments by Victor Medical Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06948710441208 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Victor Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000021121
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED b8bbc8d6-1b7c-45a6-bd77-87bb22b0f41c 61 fields · synced Jun 19, 2026