Identity
- Trade Name
- Sil.Flex-2 Mask, #5 EUDAMED
- Device Name
- Reusable Mask EUDAMEDReusable Silicone Mask EUDAMED
- Model / Reference
- AM0086 EUDAMED(O) Mask EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980100543 EUDAMED04710810083204 EUDAMED
- Basic UDI-DI
- 69239801NR2KBSG EUDAMED471081008RNOMAP EUDAMED
- Direct Marketing DI
- 04710810083204 EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMEDR03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDNetherlands 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
Sil.Flex-2 Mask, #5 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 | 69239801NR2KBSG | 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 792ade65-1597-4261-a84e-a1884b8326c0 61 fields · synced Jul 17, 2026
- EUDAMED a506a480-051a-44b6-800c-25ef0ee7f4d5 61 fields · synced Jul 17, 2026