Identity
- Trade Name
- Lapbag Non Metal Plus Type EUDAMED
- Device Name
- Lapbag Non Metal Plus Type EUDAMED
- Model / Reference
- B12-1005A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806182206696 EUDAMED
- Basic UDI-DI
- B-08806182206696 EUDAMED
- EMDN Code
- S01010301 FLAT STERILISATION POUCHES, POLYETHYLENE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Lapbag Non Metal Plus Type by Sejong Medical Co., Ltd — Class IIa — 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-08806182206696 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEJONG MEDICAL Co., Ltd.
- EUDAMED SRN
- KR-MF-000020090
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED beab73e0-8922-403d-9508-5db9e8dabaff 61 fields · synced Jul 25, 2026