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Resuscitation Mask Large Infant
EUDAMEDClass IIa (EU MDR)
Ref XTF0027Model (O) Mask
Identity
- Trade Name
- RESUSCITATION MASK LARGE INFANT EUDAMED
- Device Name
- Reusable Silicone Mask EUDAMED
- Model / Reference
- (O) Mask EUDAMEDXTF0027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 44026704615702 EUDAMED
- Basic UDI-DI
- 471081008RNOMAP EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Resuscitation Mask Large Infant by GaleMed Corporation — 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 | 471081008RNOMAP | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 58b7d734-a636-4e99-9274-b9eca6ea3cde 61 fields · synced Jul 14, 2026