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Airsoft Mask, #5 w/Valve
EUDAMEDClass IIa (EU MDR)
Ref AM0031Model (O) MaskRef AM0096
Identity
- Trade Name
- Airsoft Mask, #5 w/Valve EUDAMEDAirsoft Mask, #5 EUDAMED
- Device Name
- Airsoft Mask EUDAMED
- Model / Reference
- (O) Mask EUDAMEDAM0031 EUDAMEDAM0096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810082429 EUDAMED04710810082481 EUDAMED
- Basic UDI-DI
- 471081008NNO185 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
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
Airsoft Mask, #5 w/Valve 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 | 471081008NNO185 | 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 (2)
- EUDAMED bdd8eec7-ba7c-4d0a-9f50-bca0d084a34f 61 fields · synced Jul 31, 2026
- EUDAMED 7d217771-6aa8-4557-b196-c8d5331394b0 61 fields · synced May 16, 2026