Identity
- Trade Name
- Lapbag EUDAMED
- Device Name
- Metal Handle Type EUDAMED
- Model / Reference
- HB11-1002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806182207334 EUDAMED
- Basic UDI-DI
- B-08806182207334 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 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-08806182207334 | 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 63722dda-c988-43fd-ac5b-c09aff96ed8a 61 fields · synced Jul 28, 2026