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Enema Irrigation Kit
EUDAMEDClass I (EU MDR)
Ref MG-INT-EIK01Model Enema Irrigation Kit
by Fbgc Limited
Identity
- Trade Name
- Enema Irrigation Kit EUDAMED
- Device Name
- Enema Irrigation Kit EUDAMED
- Model / Reference
- Enema Irrigation Kit EUDAMEDMG-INT-EIK01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060551221342 EUDAMED
- Basic UDI-DI
- 5060551Enema5Z EUDAMED
- EMDN Code
- G02060303 BALLOON CATHETERS, BARIUM ENEMA EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Enema Irrigation Kit by Fbgc Limited — Class I — 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 | 5060551Enema5Z | Class I | Active |
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Manufacturer
- Manufacturer
- Fbgc Limited
- EUDAMED SRN
- UK-MF-000046785
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 64c7f429-b0dd-4e01-81c2-682cc81690a2 61 fields · synced Jun 18, 2026