Identity
- Trade Name
- Sil.Flex-2 Mask, #3 EUDAMEDSil-Flex FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Reusable Mask EUDAMEDReusable Silicone Mask EUDAMEDNew Sil-Flex Silicone Mask size 3, Child Large FDA UDI
- Model / Reference
- AM0023 EUDAMED(O) Mask EUDAMED5181 FDA UDI
- Description
- New Sil-Flex Silicone Mask size 3, Child Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06923980100529 EUDAMED04710810083198 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801NR2KBSG EUDAMED471081008RNOMAP EUDAMED
- Direct Marketing DI
- 04710810083198 EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMEDR03010201 AIR/OXYGEN MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5550 FDA UDI
- Market of Registration
- France EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sil.Flex-2 Mask, #3 by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69239801NR2KBSG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (3)
- EUDAMED 9b0fc0dd-53de-4996-b628-f84c0d38f0f0 61 fields · synced Jul 23, 2026
- FDA UDI b686b1c3-c85f-4a9c-96a9-da5cea5ee4f7 34 fields · synced May 30, 2026
- EUDAMED 4469cff2-e452-4356-afce-48fa3951baa1 61 fields · synced Jul 23, 2026