Identity
- Trade Name
- Urine monitor EUDAMED
- Device Name
- Urine monitor EUDAMED
- Model / Reference
- UM100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562301643 EUDAMED
- Basic UDI-DI
- 69325623100284D EUDAMED
- EMDN Code
- A06030302 HOURLY DIURESIS MEASUREMENT SETS EUDAMED
Classification
- Device Class
- Class I 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
Urine monitor by Guangdong Biolight Meditech Co., Ltd — Class I — 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 | 69325623100284D | Class I | 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 a0a4582f-05b8-42e1-8b41-c5dca718fa14 61 fields · synced Jul 15, 2026