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Specialized Fetal & Maternal Monitor
EUDAMEDClass IIb (EU MDR)
Ref C26Model C10
Identity
- Trade Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Device Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Model / Reference
- C10 EUDAMEDC26 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020595 EUDAMED
- Basic UDI-DI
- 69454290FM001KU EUDAMEDB-06945429020595 EUDAMED
- Direct Marketing DI
- 06945429020595 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMEDBelgium 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69454290FM001KU | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69454290FM001KU | 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 (2)
- EUDAMED fc9eb0a0-2612-48e4-a863-760ca7308236 61 fields · synced Oct 6, 2026
- EUDAMED 218e4519-43cc-4dab-86fc-4e25a0894286 61 fields · synced May 19, 2026