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Linear Cutting Stapler and Single Use Loading Unit
EUDAMEDClass IIb (EU MDR)
Ref QOLC8048S
Identity
- Device Name
- Linear Cutting Stapler and Single Use Loading Unit EUDAMED
- Model / Reference
- QOLC8048S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974710252346 EUDAMED
- Basic UDI-DI
- B-06974710252346 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
Linear Cutting Stapler and Single Use Loading Unit by Miconvey Technologies Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06974710252346 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Miconvey Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031532
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED dfde56c2-d2d2-45ab-a3e2-e4c8d690acbf 61 fields · synced Jun 9, 2026