Identity
- Trade Name
- Handheld monitor EUDAMED
- Device Name
- Handheld monitor EUDAMED
- Model / Reference
- M860 EUDAMEDM850 EUDAMEDM880 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300301 EUDAMED06932562300295 EUDAMED06932562300318 EUDAMED
- Basic UDI-DI
- 693256231002343 EUDAMED69325623100103S EUDAMED693256231002445 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
Handheld 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131762 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 693256231002343 | 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 (4)
- EUDAMED 9e09f63f-45cb-4f41-b1fe-9196bb64d94e 61 fields · synced Jul 18, 2026
- EUDAMED d48b1f2f-4206-4d85-a6fd-08f062389247 61 fields · synced May 17, 2026
- EUDAMED f2436bd7-3580-45ac-90b7-f2ecf088b088 61 fields · synced May 18, 2026
- FDA 510(k) K131762 1 fields · synced May 18, 2026