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Respiratory Humidifier
EUDAMEDClass IIb (EU MDR)
Ref 112000145Model NeoHif-i7/NeoHif-i5Ref 112000129Model NeoHif-i7
Identity
- Trade Name
- Respiratory Humidifier EUDAMED
- Device Name
- Respiratory Humidifier EUDAMED
- Model / Reference
- NeoHif-i7/NeoHif-i5 EUDAMED112000145 EUDAMEDNeoHif-i7 EUDAMED112000129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733991297 EUDAMED
- Basic UDI-DI
- 697273399RHNeoHiFi5i7SN EUDAMEDB-06972733991297 EUDAMED
- Direct Marketing DI
- 06972733991297 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697273399RHNeoHiFi5i7SN | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697273399RHNeoHiFi5i7SN | 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 32c525db-8a1b-4908-b37c-8aeadf6a9360 61 fields · synced Jul 30, 2026
- EUDAMED c7bf7138-c919-4419-87b4-e53f2dccdf86 61 fields · synced May 18, 2026