Identity
- Trade Name
- Roll Stand mounting plate BiPAP A-series EUDAMED
- Device Name
- CPAP and BiPAP EUDAMED
- Model / Reference
- 1115268 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959412873 EUDAMED
- Basic UDI-DI
- 0606959BM136LW EUDAMED
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Roll Stand mounting plate BiPAP A-series by Respironics, Inc. — Class I — 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 | 0606959BM136LW | Class I | 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 1395dbad-234b-4922-8408-2dbd0ab6d602 61 fields · synced Jul 31, 2026
- EUDAMED ee7e1ac1-0537-450d-9721-44456c8b2d12 61 fields · synced Jul 31, 2026