Identity
- Trade Name
- Fetal Monitor EUDAMED
- Device Name
- Fetal Monitor EUDAMED
- Model / Reference
- CMS800G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040100195 EUDAMED
- Basic UDI-DI
- 69450401CMS800GFM EUDAMED
- Direct Marketing DI
- 06945040100195 EUDAMED
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Fetal Monitor by Contec Medical Systems Co., Ltd. — Class IIa — 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 | 69450401CMS800GFM | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 85f1977a-e688-42b1-971f-02c4b3a88041 61 fields · synced Jul 16, 2026