Identity
- Trade Name
- AEROCHAMBER PLUS EUDAMED
- Device Name
- AeroChamber Plus* Adult Mouthpiece EUDAMED
- Model / Reference
- 101501 EUDAMED101501 / 101501100070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860015012 EUDAMED
- Basic UDI-DI
- B-00762860015012 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Aerochamber Plus by Trudell Medical International — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function analysis system, adult.
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- VISCOFLU — PHARMA LINE Srl · Class IIb
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Demand Valve, 3M Hose - AGA (NORDIC) Probe — BNOS MediTECH · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00762860015012 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trudell Medical International
- EUDAMED SRN
- CA-MF-000009860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 9ffc74fb-f68c-4086-85cc-5f2f17900615 61 fields · synced May 23, 2026