Identity
- Trade Name
- Lullaby IV Pole EUDAMED
- Device Name
- IV Pole EUDAMED
- Model / Reference
- 2041600-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682142649 EUDAMED
- Basic UDI-DI
- 8406821BUG00128H7 EUDAMED
- Direct Marketing DI
- 00840682142649 EUDAMED
- EMDN Code
- Z12030380 INFUSION INSTRUMENTS - HARDWARE ACCESSORIES 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
Lullaby IV Pole by Datex-Ohmeda 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 | 8406821BUG00128H7 | 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 90af6642-67f4-42a6-a4d8-eb6080e2882e 61 fields · synced Sep 18, 2026