Identity
- Device Name
- ComfiKit Standard IUCD Fitting Pack EUDAMED
- Model / Reference
- 8574 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05010058085749 EUDAMED
- Basic UDI-DI
- 50100580A22sG002T00AW9 EUDAMED
- EMDN Code
- K01020120 MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Gynaecological Procedure packs for standard gynaecological procedures relating to the insertion management or removal of Inter-Uterine Device EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
ComfiKit Standard IUCD Fitting Pack by Robinson Healthcare 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 | 50100580A22sG002T00AW9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Robinson Healthcare Ltd
- EUDAMED SRN
- GB-PR-000028360
Sources (1)
- EUDAMED 4af79585-4a51-46c0-a951-cf9555d282f5 61 fields · synced Jul 27, 2026