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Softip-1 Nasal Cannula, Adult
EUDAMEDClass IIa (EU MDR)
Ref AO0069Model (D) Oxygen TherapyRef AO0068
Identity
- Trade Name
- Softip-1 Nasal Cannula, Adult EUDAMED
- Device Name
- Nasal Cannula EUDAMED
- Model / Reference
- (D) Oxygen Therapy EUDAMEDAO0069 EUDAMEDAO0068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810106361 EUDAMED04710810082764 EUDAMED
- Basic UDI-DI
- 471081008NNDO8W 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
Softip-1 Nasal Cannula, Adult 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 | 471081008NNDO8W | 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 (2)
- EUDAMED ea48e9de-8c42-4fb7-a630-f26064de7626 61 fields · synced Jul 22, 2026
- EUDAMED 48854069-1a72-4ef9-b985-90ab91bb14d3 61 fields · synced May 18, 2026