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R7 Resuscitator, Child w/Mask, Reservoir
EUDAMEDClass IIa (EU MDR)
Ref AR0067Model (L) Resuscitator
Identity
- Trade Name
- R7 Resuscitator, Child w/Mask, Reservoir EUDAMED
- Device Name
- Reusable Resuscitator EUDAMED
- Model / Reference
- (L) Resuscitator EUDAMEDAR0067 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810080122 EUDAMED
- Basic UDI-DI
- 471081008RNLRAQ EUDAMED
- Direct Marketing DI
- 24710810080122 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS 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
R7 Resuscitator, Child w/Mask, Reservoir 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 | 471081008RNLRAQ | 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 b78f514e-e8c9-4f50-b51e-700327452f32 61 fields · synced Jun 19, 2026