Identity
- Trade Name
- Reusable Silicone Mask Size: 3 EUDAMED
- Device Name
- Reusable Mask EUDAMED
- Model / Reference
- XTA0099 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980112201 EUDAMED
- Basic UDI-DI
- 69239801NR2KBSG EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Reusable Silicone Mask Size: 3 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 0ad29980-05c9-4dfc-b0e6-71b2a770ef0c 61 fields · synced Jul 30, 2026
- EUDAMED 3d253bdd-d730-41b4-9b50-fbeca61f69b7 61 fields · synced Jul 30, 2026