Identity
- Device Name
- Detachable Endo Pocket EUDAMED
- Model / Reference
- FEP957100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127863511 EUDAMED
- Basic UDI-DI
- B-04714127863511 EUDAMED
- EMDN Code
- K01020107 MINIMALLY INVASIVE SURGERY RECOVERY BAGS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Detachable Endo Pocket by Unimax Medical Systems Inc. — 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-04714127863511 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- EUDAMED SRN
- TW-MF-000008895
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED eadcf487-af4f-43a1-a6db-c861bec279ff 61 fields · synced Oct 7, 2026