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nTest Lung Module, R90
EUDAMEDClass I (EU MDR)
Ref AB0055Model (V) Test lungRef AB0051
Identity
- Trade Name
- nTest Lung Module, R90 EUDAMED
- Device Name
- Test lung EUDAMED
- Model / Reference
- (V) Test lung EUDAMEDAB0055 EUDAMEDAB0051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810100967 EUDAMED24710810100929 EUDAMED
- Basic UDI-DI
- 471081008NNVB9S EUDAMED
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
nTest Lung Module, R90 by GaleMed Corporation — 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 | 471081008NNVB9S | Class I | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c2b61bdb-cc76-4731-b338-fdd540b3ac13 61 fields · synced Jul 12, 2026
- EUDAMED 1ddebac0-79b1-4bb0-b327-f21dc99b45f7 61 fields · synced May 18, 2026