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Specialized Fetal & Maternal Monitor
EUDAMEDClass IIb (EU MDR)
Ref C11Model C10
Identity
- Trade Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Device Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Model / Reference
- C11 EUDAMEDC10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020663 EUDAMED
- Basic UDI-DI
- B-06945429020663 EUDAMED69454290FM001KU EUDAMED
- Direct Marketing DI
- 06945429020663 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMEDIreland 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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06945429020663 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06945429020663 | 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 d5406348-ecd3-4b80-8052-03f58a4cf6b8 61 fields · synced Oct 6, 2026
- EUDAMED 9926ee09-6c21-4308-bf5a-56ac40dc32d7 61 fields · synced May 19, 2026