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Adj PEEP Valve, 2-10cmH2O, 22/15mm, PSF
EUDAMEDClass IIa (EU MDR)
Ref AV0016Model (H) Ventilation Circuit
Identity
- Trade Name
- Adj PEEP Valve, 2-10cmH2O, 22/15mm, PSF EUDAMED
- Device Name
- Reusable Peep valve EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAV0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 44710810083639 EUDAMED
- Basic UDI-DI
- 471081008RNH48J EUDAMED
- Direct Marketing DI
- 44710810083639 EUDAMED
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER 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
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
Adj PEEP Valve, 2-10cmH2O, 22/15mm, PSF 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 | 471081008RNH48J | 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 1381ef1b-35d7-461e-8b45-b03e20b0b007 61 fields · synced Jul 9, 2026