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Comfort-in
EUDAMEDClass IIb (EU MDR)
Ref AD-NV-30Ref CF-DV-02-NRef AD-VIAL-30Ref CAP-02-50Ref AD-PEN-20Ref CF-DV-02-SRef AD-VIAL-20Ref CF-DV-01-SRef CF-DV-01-IMRef CF-DV-01-NRef NZ-70Ref AD-DENTAL-30
Identity
- Trade Name
- Comfort-in EUDAMED
- Device Name
- Needle free soft injection system EUDAMED
- Model / Reference
- AD-NV-30 EUDAMEDCF-DV-02-N EUDAMEDAD-VIAL-30 EUDAMEDCAP-02-50 EUDAMEDAD-PEN-20 EUDAMEDCF-DV-02-S EUDAMEDAD-VIAL-20 EUDAMEDCF-DV-01-S EUDAMEDCF-DV-01-IM EUDAMEDCF-DV-01-N EUDAMEDNZ-70 EUDAMEDAD-DENTAL-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809230109093 EUDAMED08809230109352 EUDAMED08809230109048 EUDAMED08809230109017 EUDAMED08809230108966 EUDAMED08809230109338 EUDAMED08809230108942 EUDAMED08809230109154 EUDAMED08809230109161 EUDAMED08809230109024 EUDAMED08809230109031 EUDAMED08809230109055 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
Yes
EUDAMEDEUDAMED
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 (12)
- EUDAMED 4e8992cc-c6ef-4825-9488-4456eca86b85 61 fields · synced Aug 2, 2026
- EUDAMED 879ac73e-1429-4339-98df-b176d24c8755 61 fields · synced May 11, 2026
- EUDAMED 00cc6242-0344-46a5-83c3-4ed5b8c3f2d4 61 fields · synced May 16, 2026
- EUDAMED 77e5af54-9aa1-43a1-b007-9c1fe8b6f255 61 fields · synced May 17, 2026
- EUDAMED f556abdc-a13c-4708-9e6e-20445f23daff 61 fields · synced May 17, 2026
- EUDAMED 4667236d-45f9-4988-b511-68245c92fcb1 61 fields · synced May 17, 2026
- EUDAMED a99cb003-e92e-4fc9-a940-267dee674ce1 61 fields · synced May 18, 2026
- EUDAMED 48406c3a-bb81-41e0-851a-2754ef873d2a 61 fields · synced May 18, 2026
- EUDAMED d0d55ead-0238-4f20-bd70-dfca577a5418 61 fields · synced May 18, 2026
- EUDAMED 8d74b2cf-4079-4cbc-a10c-e6abce3f2b69 61 fields · synced May 18, 2026
- EUDAMED f2c4b09c-3441-43df-993c-51615cbc7d5f 61 fields · synced May 18, 2026
- EUDAMED e851f366-0d00-4b90-ab96-a6f5658db957 61 fields · synced May 18, 2026