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BiPAP Auto BiFlex, w/HT Humid System One 60 Series, INTL
EUDAMEDClass IIa (EU MDR)
Ref IN761TS
Identity
- Trade Name
- BiPAP Auto BiFlex, w/HT Humid System One 60 Series, INTL EUDAMED
- Device Name
- REMstar System (60 Series) EUDAMED
- Model / Reference
- IN761TS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959069381 EUDAMED
- Basic UDI-DI
- B-00606959069381 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
BiPAP Auto BiFlex, w/HT Humid System One 60 Series, INTL 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-00606959069381 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED d90b73a1-6719-4285-b017-10dc49a876f5 61 fields · synced Oct 7, 2026
- EUDAMED ce1d5ece-efe8-4c03-91a9-a28816d99f37 61 fields · synced Jul 13, 2026