Identity
- Trade Name
- Softip-1 Nasal Cannula, Child EUDAMEDFDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- Disposable Oxygen therapy EUDAMEDSoftip-1 Nasal Cannula, Child FDA UDI
- Model / Reference
- AO0067 EUDAMEDFDA UDI
- Description
- Softip-1 Nasal Cannula, Child FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06923980105999 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801ND2MAPJ EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- R0301020301 OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES) EUDAMED
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5340 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
No
FDA UDI
Softip-1 Nasal Cannula, Child 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 | 69239801ND2MAPJ | 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 16f3d9b8-3e91-4a22-9f9f-997918f58799 61 fields · synced Jun 19, 2026
- FDA UDI 7552da58-b51e-42d8-8c6a-903ef9fb3f84 33 fields · synced May 30, 2026