Identity
- Trade Name
- Endo-Bag EUDAMED
- Device Name
- Endo Bag EUDAMED
- Model / Reference
- EB/EBH Series EUDAMEDEB-0709 EUDAMEDEB-0507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123029232 EUDAMED04714123020840 EUDAMED
- Basic UDI-DI
- 471412302EB-01P3 EUDAMED
- EMDN Code
- K01020107 MINIMALLY INVASIVE SURGERY RECOVERY BAGS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Endo-Bag by Lagis Enterprise Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471412302EB-01P3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000007081
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a38e6a49-ec0c-4cf0-a7d1-9b0ce6bc1a6d 61 fields · synced Aug 1, 2026
- EUDAMED c789d524-4fc6-4570-9c61-7c847ec02b03 61 fields · synced May 18, 2026