Identity
- Trade Name
- Test Lung, 1L EUDAMED
- Device Name
- Lung simulator EUDAMED
- Model / Reference
- AB0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980103308 EUDAMED
- Basic UDI-DI
- 69239801NR1IAS3 EUDAMED
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Gas-sampling/monitoring respiratory tubing, single-use
Test Lung, 1L by GaleMed (Xiamen) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gas-sampling/monitoring respiratory tubing, single-use.
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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 | 69239801NR1IAS3 | Class I | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 55be56a6-b8eb-4579-9bac-e201b0012e64 61 fields · synced Jun 19, 2026