Identity
- Trade Name
- Comfort-in EUDAMED
- Device Name
- Needle free soft injection system EUDAMED
- Model / Reference
- CF-DV-01-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809230109147 EUDAMED
- Basic UDI-DI
- 880923010Comfort-inMQ EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Comfort-in by MIKA Medical Co. — Class IIb — 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 | 880923010Comfort-inMQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- MIKA Medical Co.
- EUDAMED SRN
- KR-MF-000019144
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED ba9011da-f6a6-4a37-8c0a-6928afa0ea54 61 fields · synced Jun 18, 2026