Identity
- Trade Name
- NEONATE-DUAL-EHW-W/O CB EUDAMED
- Device Name
- NEONATE-DUAL-EHW-W/O CB EUDAMED
- Model / Reference
- FMMD2039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876360632 EUDAMED
- Basic UDI-DI
- B-04719876360632 EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ventilator breathing circuit, single-use
Neonate-Dual-Ehw-W/O Cb by Foxxmed Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, single-use.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- MEDIFLEX — Mediflex Medikal · Class IIa
- ALTECH — Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. · Class IIa
- Infant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- AirLife™ — Airlife, Inc. · Class II
- Classic RT — Plastiflex Group NV · Class I
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-04719876360632 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foxxmed Ltd
- EUDAMED SRN
- TW-MF-000022145
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b02a4a74-5919-4b82-ae86-80620e8ad53e 61 fields · synced Jun 18, 2026