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Specialized Fetal & Maternal Monitor
EUDAMEDClass IIb (EU MDR)
Ref C22AModel C10
Identity
- Trade Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Device Name
- Specialized Fetal & Maternal Monitor EUDAMED
- Model / Reference
- C22A EUDAMEDC10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020625 EUDAMED
- Basic UDI-DI
- B-06945429020625 EUDAMED69454290FM001KU EUDAMED
- Direct Marketing DI
- 06945429020625 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-06945429020625 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06945429020625 | 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 6d597a4d-9190-4dcd-b7c0-3fc5ea87d958 61 fields · synced Oct 6, 2026
- EUDAMED 2fb5e416-6759-4f80-b005-790ad4123494 61 fields · synced May 19, 2026