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REMSTAR HEATED HUMIDIFIER INTL - RP Kit
EUDAMEDClass IIa (EU MDR)
Ref 1038807Model REMstar Heated Humidifier
Identity
- Trade Name
- REMSTAR HEATED HUMIDIFIER INTL - RP Kit EUDAMED
- Model / Reference
- REMstar Heated Humidifier EUDAMED1038807 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959020412 EUDAMED
- Basic UDI-DI
- B-00606959020412 EUDAMED
- EMDN Code
- R060201 ACTIVE VENTILATION HUMIDIFICATION SYSTEMS, EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
REMSTAR HEATED HUMIDIFIER INTL - RP Kit by Respironics, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959020412 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED cc7ead22-1f10-433e-848d-d2957669e292 61 fields · synced Jun 19, 2026
- EUDAMED e72f38fc-23b6-45d3-a3e4-39f0f3c3e14d 61 fields · synced Jun 19, 2026