Identity
- Trade Name
- Open Cuff Silicone Face Mask #4 EUDAMEDAmbu FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Reusable Mask EUDAMEDOpen Cuff Silicone Face Mask Reusable Face Mask #4 FDA UDI
- Model / Reference
- XAM0005 EUDAMEDFDA UDI
- Description
- Open Cuff Silicone Face Mask Reusable Face Mask #4 FDA UDI
Identifiers
- Catalog Number
- 000251005 FDA UDI
- Primary DI / UDI-DI
- 06923980100598 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801NR2KBSG EUDAMED
- Direct Marketing DI
- 06923980100598 EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER 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
- Germany 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
Yes
FDA UDI
Open Cuff Silicone Face Mask #4 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 (2)
- EUDAMED 55976b7d-cd08-4ae3-af7f-1efe3469b105 61 fields · synced Jun 18, 2026
- FDA UDI b3d5c569-16b5-460e-8a1d-cb7ccbd53314 34 fields · synced May 30, 2026