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EMT w/Mouth Piece, PEEP Valve 5~20cmH2O
EUDAMEDClass I (EU MDR)
Ref AL0003Model (a) EMTRef XMI0001
Identity
- Trade Name
- EMT w/Mouth Piece, PEEP Valve 5~20cmH2O EUDAMED
- Device Name
- EMT EUDAMEDReusable EMT EUDAMED
- Model / Reference
- (a) EMT EUDAMEDAL0003 EUDAMEDXMI0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810112805 EUDAMED04710810107498 EUDAMED
- Basic UDI-DI
- 471081008NNaLAY EUDAMED471081008RNaLBU EUDAMED
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS 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
EMT w/Mouth Piece, PEEP Valve 5~20cmH2O 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 | 471081008NNaLAY | 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 a021dce9-2844-44f2-b2fc-c6d318fa1718 61 fields · synced Jul 25, 2026
- EUDAMED 91ebe3c8-7d33-4d73-8518-427115fb4462 61 fields · synced May 18, 2026