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Respiratory Humidifier
EUDAMEDClass IIb (EU MDR)
Ref 112000128Model NeoHif-i5Model NeoHif-i7/NeoHif-i5
Identity
- Trade Name
- Respiratory Humidifier EUDAMED
- Device Name
- Respiratory Humidifier EUDAMED
- Model / Reference
- NeoHif-i5 EUDAMED112000128 EUDAMEDNeoHif-i7/NeoHif-i5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733991280 EUDAMED
- Basic UDI-DI
- B-06972733991280 EUDAMED697273399RHNeoHiFi5i7SN EUDAMED
- Direct Marketing DI
- 06972733991280 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania EUDAMEDGreece 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Respiratory Humidifier by HEYER Medical Co., Ltd. — Class IIb — 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-06972733991280 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06972733991280 | Class IIb | Active |
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Manufacturer
- Manufacturer
- HEYER Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014712
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 2e1b5812-fe92-4116-9e8a-bd5cd50200c5 61 fields · synced Oct 6, 2026
- EUDAMED 259a24e4-18d8-4f84-b171-44d8d3e107c5 61 fields · synced May 17, 2026