Identity
- Trade Name
- Patient monitor EUDAMED
- Device Name
- Patient monitor EUDAMED
- Model / Reference
- P12 EUDAMEDP18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300042 EUDAMED
- Basic UDI-DI
- 69325623100013R 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 Guangdong Biolight Meditech 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 | 69325623100013R | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c95f7ee2-dcdb-40b3-a5b5-cac66c98be82 61 fields · synced May 23, 2026