Identity
- Trade Name
- Dorma 400, DE- RENTAL EUDAMED
- Device Name
- REMstar, REMstar SE, Dorma EUDAMED
- Model / Reference
- RDEV402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959410787 EUDAMED
- Basic UDI-DI
- B-00606959410787 EUDAMED
- EMDN Code
- Z1203010502 ADULT PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Dorma 400, DE- RENTAL 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-00606959410787 | 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 (1)
- EUDAMED 6ca50045-e4c0-4334-89fe-91ddce148bdf 61 fields · synced Jun 18, 2026