Identity
- Trade Name
- Vital signs monitor EUDAMED
- Device Name
- Vital signs monitor EUDAMED
- Model / Reference
- V6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300271 EUDAMED
- Basic UDI-DI
- 693256231000949 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
Vital signs monitor by Guangdong Biolight Meditech Co., Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153135 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K113833 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 693256231000949 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- FDA Applicant
- Guangdong Biolight Meditech Co., Ltd.
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 294ed7a1-7004-488d-b378-ae3918e851ab 85 fields · synced Jun 18, 2026
- FDA 510(k) K153135 1 fields · synced May 18, 2026