Identity
- Trade Name
- Patient monitor EUDAMED
- Device Name
- multi-parameter patient monitor EUDAMED
- Model / Reference
- PM12B/PM12D EUDAMEDPM12E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070970093 EUDAMED
- Basic UDI-DI
- 6975070970031B3 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Patient monitor by Shenzhen Le Medical Technology Co., Ltd. — Class IIb — 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 | 6975070970031B3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Le Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007686
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6ef10ce9-87f0-4ffa-b6fe-fa64771eab50 61 fields · synced Oct 6, 2026