Identity
- Trade Name
- Airsoft Mask, #5 w/Valve EUDAMEDAirsoft Mask, #5 EUDAMED
- Device Name
- Disposable Mask EUDAMED
- Model / Reference
- AM0031 EUDAMEDAM0096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980101397 EUDAMED06923980101304 EUDAMED
- Basic UDI-DI
- 69239801ND2KDPJ EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDGermany 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 (Xiamen) Co., Ltd. — 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 | 69239801ND2KDPJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3756b87e-a543-4b7d-9515-8675ac648b36 61 fields · synced Jul 9, 2026
- EUDAMED 1bb11c02-93c1-4529-b450-ec02829fbf3d 61 fields · synced May 17, 2026