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Hyperinflation Kit, 1L
EUDAMEDClass IIa (EU MDR)
Ref AB0157Model (R) Emergency Care
Identity
- Trade Name
- Hyperinflation Kit, 1L EUDAMED
- Device Name
- Hyperinflation Kit EUDAMED
- Model / Reference
- (R) Emergency Care EUDAMEDAB0157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810112409 EUDAMED
- Basic UDI-DI
- 471081008NNRRAE EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Hyperinflation Kit, 1L by GaleMed Corporation — Class IIa — 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 | 471081008NNRRAE | Class IIa | 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 439587e6-faaf-40a1-ab95-db035a7f1feb 61 fields · synced Sep 30, 2026