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Respiratory Tract Humidifiers for Medical Use
EUDAMEDClass IIa (EU MDR)
Ref 7100RModel 7100R、7300RRef 7300R
Identity
- Trade Name
- Respiratory Tract Humidifiers for Medical Use EUDAMED
- Device Name
- Respiratory Tract Humidifiers for Medical Use EUDAMED
- Model / Reference
- 7100R、7300R EUDAMED7100R EUDAMED7300R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970966664476 EUDAMED06970966664483 EUDAMED
- Basic UDI-DI
- B-06970966664476 EUDAMED6970966660030DY EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Respiratory Tract Humidifiers for Medical Use by Gentec (shanghai) Corporation — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970966664476 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970966664476 | 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 (3)
- EUDAMED f06ff788-ffec-4bc7-a2c8-3f0191e21544 61 fields · synced Jul 19, 2026
- EUDAMED d5c2fdbe-9e7a-4e8e-a9aa-8e4ffb5f2ff7 61 fields · synced Jul 10, 2026
- EUDAMED 1fc6de18-a21b-4c55-8d94-b281fc803ef2 61 fields · synced Jul 19, 2026