Identity
- Trade Name
- AeroEclipse* BAN* EUDAMEDAEROECLIPSE BAN Replacement Mouthpiece Assembly FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- Accessory to AeroEclipse* BAN* Nebulizer EUDAMEDAEROECLIPSE BAN Replacement Mouthpiece Assembly FDA UDI
- Model / Reference
- 115503/115503110025 EUDAMED105509 FDA UDI
- Description
- AEROECLIPSE BAN Replacement Mouthpiece Assembly FDA UDI
Identifiers
- Catalog Number
- 10550994080 FDA UDI
- Primary DI / UDI-DI
- 00762860150010 EUDAMED62860105509026 FDA UDI
- Basic UDI-DI
- 762860NEB1LA EUDAMED
- 510(k) Number
- K080926 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R0680 NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AeroEclipse* BAN* by Trudell Medical International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 762860NEB1LA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 33998783-e497-4a00-81af-44f2a27c2e0e 61 fields · synced Jul 8, 2026
- FDA UDI 98cbf587-7af3-4be1-ab6b-64547782a91d 37 fields · synced May 24, 2026