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Lullaby Warmer - WARMER MAIN ASM, 115V for sea shipment
EUDAMEDClass IIb (EU MDR)
Ref 2061755-001
Identity
- Trade Name
- Lullaby Warmer - WARMER MAIN ASM, 115V for sea shipment EUDAMED
- Device Name
- Lullaby Warmer EUDAMED
- Model / Reference
- 2061755-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682142762 EUDAMED
- Basic UDI-DI
- 8406821BUG00391HQ EUDAMED
- Direct Marketing DI
- 00840682142762 EUDAMED
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lullaby Warmer - WARMER MAIN ASM, 115V for sea shipment 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 | 8406821BUG00391HQ | 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 6475368c-1578-40bc-8784-024feff80490 61 fields · synced Oct 6, 2026