Identity
- Trade Name
- Neonatal Incubator EUDAMED
- Device Name
- Neonatal Incubator EUDAMED
- Model / Reference
- B3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021523 EUDAMED
- Basic UDI-DI
- B-06945429021523 EUDAMED
- EMDN Code
- Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Neonatal Incubator by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — CE/MDR — 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-06945429021523 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9a40f063-8454-4e6f-bbf3-c9f2ea133a5c 61 fields · synced Oct 6, 2026