Identity
- Trade Name
- Easy Lung 1 Liter FDA UDI
- Generic Name
- Lung physical simulator FDA UDI
- Device Name
- EasyLung EUDAMEDTest lung (Physical simulator) FDA UDI
- Model / Reference
- 300.756.100 EUDAMEDFDA UDI
- Description
- Test lung (Physical simulator) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640214642691 EUDAMEDFDA UDI
- Basic UDI-DI
- 764021464T01FP EUDAMED
- FDA Product Code
- BTC FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Lung physical simulator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5320 FDA UDI
- Market of Registration
- Liechtenstein 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EasyLung by IMT Analytics AG — 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 | 764021464T01FP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IMT Analytics AG
- EUDAMED SRN
- CH-MF-000016606
- Authorised Representative
- IMT Analytics GmbH LI-AR-000003262
Sources (2)
- EUDAMED ef10ec44-1127-4154-a212-e775cde57ef4 61 fields · synced Jul 9, 2026
- FDA UDI ecb7ee42-318f-47f6-944d-efb767bb44f7 33 fields · synced May 30, 2026