Identity
- Trade Name
- SimplyGo, Battery (Extra/Replacement) EUDAMED
- Device Name
- SimplyGo Accessories EUDAMED
- Model / Reference
- 1082662 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959401365 EUDAMED
- Basic UDI-DI
- 0606959BM153LW EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS 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
SimplyGo, Battery (Extra/Replacement) 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 | 0606959BM153LW | 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 (1)
- EUDAMED aa8cb245-a4e6-4b68-83c7-ad211198d3fa 61 fields · synced Jun 17, 2026