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Comfortseal*
EUDAMEDClass I (EU MDR)
Ref 105502/105502110010Ref 105564/105564110010
Identity
- Trade Name
- COMFORTSEAL* EUDAMED
- Device Name
- Accessory to AeroEclipse* BAN* Nebulizer EUDAMED
- Model / Reference
- 105502/105502110010 EUDAMED105564/105564110010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860000841 EUDAMED00762860001558 EUDAMED
- Basic UDI-DI
- 762860NEB1LA EUDAMED
- EMDN Code
- R0680 NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMEDPortugal 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Comfortseal* by Trudell Medical International — 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 | 762860NEB1LA | Class I | Active |
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Manufacturer
- Manufacturer
- Trudell Medical International
- EUDAMED SRN
- CA-MF-000009860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e43932b6-165f-4df8-9786-f9ebdf5df1b1 61 fields · synced Jul 12, 2026
- EUDAMED 7fe1155d-40dc-446e-9f36-6f6abaea7228 61 fields · synced Jul 12, 2026