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Fetal & Maternal Monitor
EUDAMEDClass IIb (EU MDR)
Ref STAR5000HRef STAR5000BRef STAR5000FRef STAR5000D
Identity
- Trade Name
- Fetal & Maternal Monitor EUDAMED
- Device Name
- Fetal & Maternal Monitor EUDAMED
- Model / Reference
- STAR5000H EUDAMEDSTAR5000B EUDAMEDSTAR5000F EUDAMEDSTAR5000D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020571 EUDAMED06945429020526 EUDAMED06945429020564 EUDAMED06945429020540 EUDAMED
- Basic UDI-DI
- B-06945429020571 EUDAMEDB-06945429020526 EUDAMEDB-06945429020564 EUDAMEDB-06945429020540 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fetal & Maternal Monitor by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06945429020571 | 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 (4)
- EUDAMED 74c2f33c-7e6e-4bc3-b013-feeb83384310 61 fields · synced Oct 7, 2026
- EUDAMED 9db96a88-01d8-40f7-a142-b4ca59d49e55 61 fields · synced May 18, 2026
- EUDAMED 0d6cb762-2e0b-4237-b4fd-b005be4fdaf7 61 fields · synced May 18, 2026
- EUDAMED b5dca135-36c7-45cb-8c24-9a92ce8cdf17 61 fields · synced May 18, 2026