Identity
- Trade Name
- Lullaby Resus Plus – NIST EUDAMED
- Device Name
- Lullaby Resus Plus EUDAMED
- Model / Reference
- 2070100-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682142748 EUDAMED
- Basic UDI-DI
- 8406821BUG00397J4 EUDAMED
- Direct Marketing DI
- 00840682142748 EUDAMED
- EMDN Code
- Z12080499 NEONATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lullaby Resus Plus – NIST by Datex-Ohmeda Inc. — Class IIb — 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 | 8406821BUG00397J4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000002206
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED cd1e26b1-7c29-4a6a-96e8-2c17a4bbecf1 61 fields · synced Jul 8, 2026