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Specialized Fetal & Maternal Monitor
EUDAMEDClass IIb (EU MDR)
Ref CF3AModel CF3/CF3A/CF30/CF30A/CF3 R/CF3A R/CF30 R/CF30A R
Identity
- Trade Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Device Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Model / Reference
- CF3/CF3A/CF30/CF30A/CF3 R/CF3A R/CF30 R/CF30A R EUDAMEDCF3A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429062403 EUDAMED
- Basic UDI-DI
- 69454290FM003KY EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Iceland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Specialized Fetal & Maternal Monitor by Shenzhen Comen Medical Instruments Co., LTD. — 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 | 69454290FM003KY | 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 60c17946-acff-4da6-82e5-d51c4c94dc75 61 fields · synced Oct 5, 2026