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Lullaby Reusable Infant Temperature Probe
EUDAMEDClass I (EU MDR)
Ref 2044384-001
Identity
- Trade Name
- Lullaby Reusable Infant Temperature Probe EUDAMED
- Device Name
- Lullaby Reusable Infant Temperature Probe EUDAMED
- Model / Reference
- 2044384-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682144025 EUDAMED
- Basic UDI-DI
- 8406821BUG00184HH EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose patient temperature probe, reusable
Lullaby Reusable Infant Temperature Probe by Datex-Ohmeda Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8406821BUG00184HH | Class I | 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 9c7063eb-b7d9-4eee-bacc-c95ee7bd7749 61 fields · synced Jun 17, 2026