Identity
- Trade Name
- AeroTrach Plus* EUDAMEDAEROTRACH PLUS Anti-Static Valved Holding Chamber FDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- Valved Holding Chamber EUDAMEDAEROTRACH PLUS Anti-Static Valved Holding Chamber FDA UDI
- Model / Reference
- 101505 EUDAMEDFDA UDI
- Description
- AEROTRACH PLUS Anti-Static Valved Holding Chamber FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00762860000810 EUDAMED00762860015050 FDA UDI
- Basic UDI-DI
- 762860VHC1NL EUDAMED
- 510(k) Number
- K001137 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Medicine chamber spacer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
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
AeroTrach Plus* 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 | 762860VHC1NL | 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 56f55545-d4e0-4b3d-8c28-c2a945cd436d 61 fields · synced Jul 9, 2026
- FDA UDI 46fea44d-976d-4ad0-96e9-40c18956ad48 35 fields · synced May 24, 2026