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Test Lung, Hard Sided, 1.0 L
EUDAMEDClass I (EU MDR)
Ref XRE0001Model (V) Test lung
Identity
- Trade Name
- Test Lung, Hard Sided, 1.0 L EUDAMED
- Device Name
- Reusable Test lung EUDAMED
- Model / Reference
- (V) Test lung EUDAMEDXRE0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810104965 EUDAMED
- Basic UDI-DI
- 471081008RNVBAN 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
Category: Gas-sampling/monitoring respiratory tubing, single-use
Test Lung, Hard Sided, 1.0 L by GaleMed Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471081008RNVBAN | 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 (1)
- EUDAMED cc609c88-93eb-4744-a4e4-81dba64f0a45 61 fields · synced Jun 18, 2026