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Auto Chamber, adult
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AH0037Model (H) Ventilation CircuitRef AH0065Ref AH0001
Identity
- Trade Name
- Auto Chamber, adult EUDAMEDgalemed FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- Chamber EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAH0037 EUDAMEDAH0065 EUDAMEDAH0001 EUDAMED3426 FDA UDI
Identifiers
- Catalog Number
- Disposable Humidification Chamber - Auto feeding (IV:120cm) FDA UDI
- Primary DI / UDI-DI
- 44710810111240 EUDAMEDFDA UDI44710810110434 EUDAMED44710810087613 EUDAMED
- Basic UDI-DI
- 471081008NNH37L EUDAMED
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Auto Chamber, adult by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471081008NNH37L | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 6bfe7332-56e8-4c9a-904f-cb66a3ffc5ca 61 fields · synced Jul 24, 2026
- EUDAMED 8987e252-8509-4bd2-a4e7-890020a0acf9 61 fields · synced May 17, 2026
- EUDAMED 053710f3-ff17-48c9-b37b-bb0f71a6eb11 61 fields · synced May 17, 2026
- FDA UDI b298be80-5341-448d-9694-21c5bc44b680 34 fields · synced May 30, 2026