← Back to catalogue
BH-3 Bubble Humidifier
EUDAMEDClass IIa (EU MDR)
Ref AH0027Model (D) Oxygen Therapy
Identity
- Trade Name
- BH-3 Bubble Humidifier EUDAMED
- Device Name
- Bubble humidifier EUDAMED
- Model / Reference
- (D) Oxygen Therapy EUDAMEDAH0027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810110023 EUDAMED
- Basic UDI-DI
- 471081008NND77G EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
BH-3 Bubble Humidifier by GaleMed 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 | 471081008NND77G | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED e99809dd-6267-4ab7-bee0-30e5991bf2d8 61 fields · synced Jul 8, 2026