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Respiratory Humidifier
EUDAMEDClass IIb (EU MDR)
Ref 112000145Model NeoHif-i7Model NeoHif-i7/NeoHif-i5
Identity
- Trade Name
- Respiratory Humidifier EUDAMED
- Device Name
- Respiratory Humidifier EUDAMED
- Model / Reference
- NeoHif-i7 EUDAMED112000145 EUDAMEDNeoHif-i7/NeoHif-i5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733991457 EUDAMED
- Basic UDI-DI
- B-06972733991457 EUDAMED697273399RHNeoHiFi5i7SN EUDAMED
- Direct Marketing DI
- 06972733991457 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 — 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-06972733991457 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06972733991457 | 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 855cf27e-5742-4ee1-b07d-c28d818ed12d 61 fields · synced Jul 23, 2026
- EUDAMED 39255539-7c38-4759-871d-9805c157e984 61 fields · synced May 19, 2026