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High Flow Nasal Cannula
EUDAMEDClass IIa (EU MDR)
Ref 681-101 ( Adult L )Model 681-101/ 681-102/ 681-103/ 681-200/ 681-201/ 681-202/ 681-203/ 681-204Ref 681-202Model 681-101Ref 681-103 Ref 681-203
Identity
- Trade Name
- High Flow Nasal Cannula EUDAMED
- Device Name
- High Flow Nasal Cannula EUDAMED
- Model / Reference
- 681-101/ 681-102/ 681-103/ 681-200/ 681-201/ 681-202/ 681-203/ 681-204 EUDAMED681-101 ( Adult L ) EUDAMED681-101 EUDAMED681-202 EUDAMED681-103 EUDAMED681-203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970966662991 EUDAMED06970966662953 EUDAMED06970966663004 EUDAMED06970966662960 EUDAMED
- Basic UDI-DI
- 6970966660020DV EUDAMED
- EMDN Code
- R0301020302 HIGH FLOW THERAPY NASAL CANNULAS (HFNC) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
High Flow Nasal Cannula by Gentec (shanghai) 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 | 6970966660020DV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gentec (Shanghai) Corporation
- EUDAMED SRN
- CN-MF-000012841
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (5)
- EUDAMED f1cb28f6-d818-49b5-8a5d-7cc9d8369876 61 fields · synced Jul 14, 2026
- EUDAMED 9c289874-02d3-4269-a8d3-0e133cbbbfa4 61 fields · synced Jul 11, 2026
- EUDAMED 211200f4-a0e4-4941-9751-4e840bcff782 61 fields · synced Jul 11, 2026
- EUDAMED 6c4db3cc-7a00-4802-9730-25ea87f2a09e 61 fields · synced Jul 14, 2026
- EUDAMED 920e013a-3ebb-4425-bb09-0e9d0b34a8d0 61 fields · synced Jul 14, 2026