Identity
- Trade Name
- Hudson RCI, Aquapak EUDAMED
- Device Name
- Hudson RCI AquaPak Pre-Filled Bubble Humidifiers EUDAMED
- Model / Reference
- H00040CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00888277445485 EUDAMED
- Basic UDI-DI
- 0888277DC344STL8 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Hudson RCI, Aquapak by Medline Industries, LP — 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 | 0888277DC344STL8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medline Industries, LP
- EUDAMED SRN
- US-MF-000009717
- Authorised Representative
- Medline International France FR-AR-000001814
Sources (1)
- EUDAMED cf691227-29a3-40dd-bfe1-9935b62460cc 61 fields · synced Aug 3, 2026