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Linear Cutting Stapler and Single Use Loading Unit
EUDAMEDClass IIb (EU MDR)
Ref QOLC10048S
Identity
- Device Name
- Linear Cutting Stapler and Single Use Loading Unit EUDAMED
- Model / Reference
- QOLC10048S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974710252247 EUDAMED
- Basic UDI-DI
- B-06974710252247 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
Linear Cutting Stapler and Single Use Loading Unit by Miconvey Technologies Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06974710252247 | 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 3b3f3da9-05fa-419f-8911-1b555019d023 61 fields · synced Jun 9, 2026